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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · third_quarter · Q3
Biosimilars --Colombia Biologics Regulations Foreign Agricultural Biotechnology Laws and Regulations --Asynchrony of International Approvals --China Biotechnology Regulations --EU Ag Biotech Policies and Regulations TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization International Treaty on Plant Genetic Resources Intellectual Property International Enforcement --India
Source: Senate LDA
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Food and Drug Administration Safety Over Sequestration Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Trade Preferences Extension Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Trade Preferences Extension Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Foreign Agricultural Biotechnology Laws and Regulations --China Biotechnology Regulations --EU Ag Biotech Policies and Regulations Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Ag-Biotech Issues --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Trade Promotion Authority --H.R. 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --H.R. 1295: Trade Adjustment Assistance Act of 2015 IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Safe and Accurate Food Labeling Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Biosimilars --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products
Safe and Accurate Food Labeling Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals --One Health Legislation (Senate Discussion Draft) --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy
Safe and Accurate Food Labeling Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative --Patient Access to Approved Drugs --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculations --Reimbursement for Infusion Drugs under Medicare Part B
Medicare Access and CHIP Reauthorization Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Further Continuing and Security Assistance Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Further Continuing and Security Assistance Appropriations Act, 2017
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Defending Public Safety Employees' Retirement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Defending Public Safety Employees' Retirement Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Foreign Agricultural Biotechnology Laws and Regulations --China Biotechnology Regulations --EU Ag Biotech Policies and Regulations Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Ag-Biotech Issues --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Trade Promotion Authority --H.R. 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --H.R. 1295: Trade Adjustment Assistance Act of 2015 IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
PARTNER Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Commerce, Justice, Science, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Department of Defense Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
21st Century Care for Military and Veterans Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
21st Century Care for Military and Veterans Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
21st Century Care for Military and Veterans Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Department of the Interior, Environment, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Maritime Washington National Heritage Area Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Financial Services and General Government Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products House 21st Century Cures Initiative --Patient Access to Approved Drugs Senate Innovation for Healthier Americans Initiative --Patient Access to Approved Drugs Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Biosimilars --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals --One Health Legislation (Senate Discussion Draft) --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
American Research and Competitiveness Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues
Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues
Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India
PATENT Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India
PATENT Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Department of Defense Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Master Limited Partnerships Parity Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products House 21st Century Cures Initiative --Patient Access to Approved Drugs Senate Innovation for Healthier Americans Initiative --Patient Access to Approved Drugs Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Biosimilars --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Genetically Engineered (GE) Animals --One Health Legislation (Senate Discussion Draft) --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Preserve Access to Affordable Generics Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India
Medical Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Medical Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Medical Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Medical Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Medical Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Medical Innovation Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Start-up Jobs and Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
Start-up Jobs and Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
Start-up Jobs and Innovation Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
A bill to improve rangeland conditions and restore grazing levels within the Grand Staircase-Escalante National Monument, Utah.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
A bill to improve rangeland conditions and restore grazing levels within the Grand Staircase-Escalante National Monument, Utah.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
COMPETE Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
COMPETE Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
COMPETE Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
STRONG Patents Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues
STRONG Patents Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India
STRONG Patents Act of 2015
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
FDA User Fee Protection Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
FDA User Fee Protection Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
FDA User Fee Protection Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
FDA User Fee Protection Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Ensuring Access to Primary Care for Women & Children Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Ensuring Access to Primary Care for Women & Children Act
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
To amend the Internal Revenue Code to make permanent the credit for increasing research activities.
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Renewable Chemicals/Bio-based Products S. 2260: EXPIRE Act of 2014Biofuels Accelerated Depreciation Extension Production Tax Credit Extension S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S. 193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 2260: EXPIRE Act of 2014 H.R. 4855, the PARTNER Act S. 1658: The Start-up Jobs and Innovation Act HR 4855: To amend the Internal Revenue Code of 1986 to provide an exception from the passive loss rules for investments in high technology research small business pass-thru entities Tax Reform Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015
Cancer Patient Protection Act of 2013
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st Century Cures Initiative Biomarkers and Regulatory Science Improvements Communication with Healthcare Professionals Expanded Access to Investigational Drugs Expedited Pathways FDA Hiring Flexibility FDA Management and Financial Accountability Innovation Incentives Longitudinal Study of Chronic Diseases Patient Access to Approved Drugs Patient-Focused Drug Development Use of Real-World Evidence Vaccine and Anti-Microbial Resistance Product Development and Incentives Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation
Cancer Patient Protection Act of 2013
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Medicare Part B Physician-Administered Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Physician Payment Sustainable Growth Rate Formula HR 4302: Protecting Access to Medicare Act of 2014 S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2000: SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 2122: Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014
Cancer Patient Protection Act of 2013
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
21st Century Cures Initiative Patient Access to Approved DrugsReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes
Cancer Patient Protection Act of 2013
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation Sequestration of PDUFA Fees Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade & Investment Partnership Regulatory Harmonization/TransparencyDrug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act
Cancer Patient Protection Act of 2013
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014Independent Payment Advisory Board Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013
Cancer Patient Protection Act of 2013
Client: BIOTECHNOLOGY INNOVATION ORGANIZATION · Firm: BIOTECHNOLOGY INNOVATION ORGANIZATION
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Biosimilars Naming Biosimilar User Fee Act Implementation Interchangeability and Pharmacy Substitution Colombia Biologics Regulations Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Reimbursement for Innovative Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Medicare Part B Physician-Administered Products H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Program Implementation Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.R. 3547: Consolidated Appropriations Act for FY 2014 Drug Repurposing H.R. 4287/2150: Independent Innovator and Repurposing Act Transatlantic Trade and Investment Partnership Reimbursement Transparency Intellectual Property Issues Regulatory HarmonizationTransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act FDA Proposed Rule on Changes to Drug Labeling Orphan Drug Act Tax Credit Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula HR 4302: Protecting Access to Medicare Act of 2014 S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2000: SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 2122: Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Clinical Trial Data Sharing and Disclosure EU Policies
Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products House 21st Century Cures Initiative --Patient Access to Approved Drugs Senate Innovation for Healthier Americans Initiative --Patient Access to Approved Drugs Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for the National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --Implementation of the Agricultural Act of 2014, Section 9003 Funding for Biofuels --H.R. 2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015
Livestock Cloning/Product Labeling --Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals --Labeling --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ---Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Biosimilars --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming USDA/APHIS Agricultural Biotechnology Regulations --Efficient Science-Based Review of Biotech Products
Biosimilars --Biosimilar User Fee Act Implementation --Coding --Colombia Biologics Regulations --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations Diagnostics and Personalized Medicine Regulation and Oversight Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development and Procurement Issues (Non-funding) TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues --Regulatory Harmonization Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --S. 1413: FDA User Fee Protection Act --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 Drug Evaluation and Review --Compassionate Use/Expanded Access --Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Senate Innovation for Healthier Americans Initiative --Biomarkers and Regulatory Science Improvements --Combination Products --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Information Disclosures --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --PATH Act (Senate Discussion Draft) House 21st Century Cures Initiative --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence Vaccines and Infectious Diseases - General Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Government Price Reporting --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Gene Editing Technologies --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -----Report Language on Heritable Genetic Modification Restriction NIH Precision Medicine Initiative Antibiotic & Diagnostic Tax Credit --H.R. 3539: Antibiotic & Diagnostic Innovation Act
Biodefense Research, Development and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --PATH Act (Senate Discussion Draft/Innovation for Healthier Americans Initiative) --ADAPT Act (House Discussion Draft/21st Century Cures Initiative)
Patent Reform --H.R. 9: Innovation Act --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --Implementation of the America Invents Act of 2011 TransPacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Intellectual Property Issues Drug Patent Settlements --S.1137: Protecting American Talent and Entrepreneurship Act of 2015 --S. 2019: Preserve Access to Affordable Generics Act of 2015 Inter Partes Review --Implementation of the American Invents Act of 2011 --S. 632: STRONG Patents Act --S. 1137: Protecting American Talent and Entrepreneurship Act of 2015 --H.R. 9: Innovation Act Intellectual Property International Enforcement --India
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · second_quarter · Q2
Funding for the USDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees --HR 2725: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biofuels --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Department of Defense Funding of Advanced Biofuels --H.R. 2685/S.1558: Department of Defense Appropriations Act for FY 2016 --H.R.2028: Energy and Water Development and Related Agencies Appropriations Act for FY 2016, --H.R.2822: Department of the Interior, Environment, and Related Agencies Appropriations Act for FY 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S.1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Genetically Engineered (GE) Animals --One Health Legislation (Senate Discussion Draft) --H.R. 3049/S.1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 ----Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology --H.R. 1599: Safe and Accurate Food Labeling Act of 2015 --U.S. Government Policy Biosimilars --Implementation of Affordable Care Act --Interchangeability and Pharmacy Substitution --Naming --Reimbursement Policy
Foreign Agricultural Biotechnology Laws and Regulations --China Biotechnology Regulations --EU Ag Biotech Policies and Regulations Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Ag-Biotech Issues --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Trade Promotion Authority --H.R. 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --H.R. 1295: Trade Adjustment Assistance Act of 2015 IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Patent Reform --H.R. 9: Innovation Act --Implementation of the America Invents Act of 2011 --S.1137: The PATENTS Act of 2015 Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership --Intellectual Property Issues Patenting of Biological Inventions --DNA Patenting and Licensing Trade Promotion Authority --HR 2146: Bipartisan Congressional Trade Priorities and Accountability Act of 2015 --HR 1295: Trade Adjustment Assistance Act of 2015 Inter Partes Review --H.R. 2578: Commerce, Science, Justice and Related Agencies Appropriations Act of FY 2016 --Implementation of the American Invents Act of 2011 --S. 1137: The PATENTS Act of 2015 --S. 632: STRONG Patents Act of 2011 --H.R. 9: Innovation Act Colombia National Development Plan --Intellectual Property Issues IP Rights for Environmental Technologies --U.S. Government Position for U.N. Convention on Climate Change Negotiations
Renewable Chemicals/Bio-based Products --New Production Tax Credit --Expansion of Master Limited Partnerships to Renewable Chemicals --H.R. 2833/S.1656: Master Limited Partnerships Parity Act of 2015 Biofuels --Production Tax Credit Extension Research & Development Tax Credit Reforms --Extension --Permanency --H.R.880: To amend the Internal Revenue Code to make permanent the credit for increasing research activities --S. 537: COMPETE Act Capital Formation Investment Incentives --Reform of Capital Gains Rules --Reform of Net Operating Loss Rules --Reform of Passive Loss Rules --S. 341: Start-up Jobs and Innovation Act --S. 537: COMPETE Act --H.R. 2179: PARTNER Act Tax Reform --Innovation/Patent Box Orphan Drug Act Tax Credit Inversions --H.R. 2995: Department of Financial Services and Related Agencies Appropriations Act for FY 2016
Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative --Patient Access to Approved Drugs --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculations --Reimbursement for Infusion Drugs under Medicare Part B
Biosimilars --Naming --Interchangeability and Pharmacy Substitution --Implementation of Affordable Care Act --Patent Certification --Reimbursement Policy Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 340B Drug Pricing Program --Program Implementation & Oversight --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Medicaid Pricing and Rebates --Average Manufacturer Price Calculations --Implementation of Affordable Care Act Funding for FDA --H.R. 3049/S. 1800: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues Reimbursement for Innovative Products --Medicare Part D Prescription Drug Program --Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --HR 1078: Food and Drug Administration Safety over Sequestration Act of 2015 --Implementation of S. 365: Budget Control Act --S. 1413: FDA User Fee Protection Act Drug Evaluation and Review --Implementation of the FDA Safety and Innovation Act/Prescription Drug User Fee Act Orphan Drug Act Tax Credit 21st Century Cures Initiative --Biomarkers and Regulatory Science Improvements --Communication with Healthcare Professionals and Payers --Expanded Access to Investigational Drugs --Expedited Pathways --FDA Hiring Flexibility --FDA Management and Financial Accountability --Innovation Incentives --Longitudinal Study of Chronic Diseases --Patient Access to Approved Drugs --Patient-Focused Drug Development --Use of Real-World Evidence --Vaccine and Anti-Microbial Resistance Product Development and Incentives --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) --Medicare Part D Low-Income Subsidy Increased Co-Pay --Biosimilars Reimbursement Policy --Authorized Generics Reimbursement Calculation --Reimbursement for Infusion Drugs under Medicare Part B Colombia National Development Plan --Regulatory Issues --Intellectual Property Issues Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft) Trans-Pacific Partnership --Data and Intellectual Property Protections for Pharmaceuticals --Regulatory Transparency Transatlantic Trade and Investment Partnership --Regulatory Harmonization --Intellectual Property Issues --Reimbursement Transparency Medicare Physician Payment Sustainable Growth Rate Formula --H.R. 2: Medicare Access and CHIP Reauthorization Act of 2015
Funding for National Institutes of Health --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative --Longitudinal Study of Chronic Diseases Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative --H.R. 3020/S. 1695: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative --ADAPT Act (House Discussion Draft) --DISARM Act (House Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · first_quarter · 1A
Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon Review and Labeling of Food Derived From Biotechnology -H.R. 1599: Safe and Accurate Food Labeling Act of 2015 -U.S. Government Policy Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification USDA/APHIS Agricultural Biotechnology Regulations -Coexistence of Production Systems -Efficient Science-Based Review of Biotech Products
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development
World Trade Organization Special 301 Submissions Foreign Agricultural Biotechnology Laws and Regulations -China Biotechnology Regulations -Asynchrony of International Approvals -EU Ag-Biotech Policies and Regulations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Ag-Biotech Issues -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Biosimilars -Mexico Biologics Regulations -Colombia Biologics Regulations Trade Promotion Authority Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Genetically Engineered (GE) Animals -FDA Approval -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 --Amendment on GE Salmon Labeling --Amendment to Restrict FDA Approval of GE Salmon
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2015 · first_quarter · Q1
Biosimilars -Biosimilar User Fee Act Implementation -Colombia Biologics Regulations -Implementation of Affordable Care Act -Interchangeability and Pharmacy Substitution -Mexico Biologics Regulations -Naming -Patent Certification Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Vaccine Access/Financing -Adult Immunization (Senate Discussion Draft) -S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program -Implementation of Affordable Care Act -Program Implementation & Oversight -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Biodefense Research, Development, and Procurement Issues (Non-funding) TransPacific Partnership -Data and Intellectual Property Protection for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees --H.R. 1078: FDA Safety over Sequestration Act Drug Evaluation and Review -Compassionate Use/Expanded Access -Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Medicare Physician Payment Sustainable Growth Rate Formula - HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Biomarkers and Regulatory Science Improvements -Communication with Healthcare Professionals -Expanded Access to Investigational Drugs -Expedited Pathways -FDA Hiring Flexibility -FDA Management and Financial Accountability -Innovation Incentives -Longitudinal Study of Chronic Diseases -Patient Access to Approved Drugs -Patient-Focused Drug Development -Use of Real-World Evidence -Vaccine and Anti-Microbial Resistance Product Development and Incentives -ADAPT Act (House Discussion Draft) -Sunshine Act Amendments -Coding -Coverage with Evidence Development Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Vaccines and Infectious Diseases - General Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Funding for the USDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for FDA -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -S 320: Medical Innovation Act of 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biomass Crop Assistance Program -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Funding for Renewable Chemicals/Bio-based Products -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 Sequestration of PDUFA Fees -H.R. 1078: FDA Safety over Sequestration Act Funding for Biofuels -Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2016 -Department of Defense Appropriations Act for FY 2016 -Department of Defense Funding of Advanced Biofuels -Energy and Water Development and Related Agencies Appropriations Act for FY 2016 Senate Budget Resolution S. Con. Res. 11 - Amendment on Medicare non-interference provision - Amendment on compounded drugs across state lines Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative - Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Funding for National Institutes of Health -S 320: Medical Innovation Act of 2015 -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 21st Century Cures Initiative -Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
World Trade Organization Special 301 Submissions Foreign Agricultural Biotechnology Laws and Regulations -China Biotechnology Regulations -Asynchrony of International Approvals -EU Ag-Biotech Policies and Regulations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals -Regulatory Transparency Transatlantic Trade and Investment Partnership -Ag-Biotech Issues -Intellectual Property Issues -Regulatory Harmonization -Reimbursement Transparency Biosimilars -Mexico Biologics Regulations -Colombia Biologics Regulations Trade Promotion Authority Colombia National Development Plan -Regulatory Issues -Reimbursement Issues -Intellectual Property Issues
Biodefense Research, Development, and Procurement Issues (Non-funding) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016 Combating Antibiotic-Resistant Bacteria (CARB) Initiative -ADAPT Act (House Discussion Draft) Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative -Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2016
Patent Reform -H.R. 9: Innovation Act -Targeting Rogue and Opaque Letters (TROL) Act of 2015 (Discussion Draft) -Implementation of the America Invents Act of 2011 -S. 632: STRONG Patents Act Inter Partes Review - S. 632: STRONG Patents Act - Implementation of the America Invents Act of 2011 World Trade Organization Special 301 Submissions IP Rights for Environmental Technologies - U.S. Government Position for U.N. Convention on Climate Change Negotiations TransPacific Partnership -Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership -Intellectual Property Issues Patenting of Biological Inventions -PTO Examination Guidelines Trade Promotion Authority Colombia National Development Plan -Intellectual Property Issues
Biofuels -Production Tax Credit Extension Research & Development Tax Credit Reforms -Permanency -Extension -S. 537: COMPETE Act -S. 341: Start-up Jobs and Innovation Act Capital Formation Investment Incentives -Reform of Capital Gains Rules -Reform of Net Operating Loss Rules -Reform of Passive Loss Rules -S. 341: Start-up Jobs and Innovation Act -S. 537: COMPETE Act -PARTNER Act (House Discussion Draft) Renewable Chemicals/Bio-based Products -New Production Tax Credit -Expansion of Master Limited Partnerships to Renewable Chemicals Tax Reform Orphan Drug Act Tax Credit
Independent Payment Advisory Board Reimbursement for Innovative Products -Medicare Part D Prescription Drug Program -Medicare Part B Physician-Administered Products Medicare Physician Payment Sustainable Growth Rate Formula -HR 2: Medicare Access and CHIP Reauthorization Act of 2015 21st Century Cures Initiative -Patient Access to Approved Drugs -Coding -Coverage with Evidence Development
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · fourth_quarter · Q4
Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International ApprovalsWorld Trade Organization Special 301 Submissions TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Reimbursement Transparency Biosimilars Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Trade Promotion Authority H.R. 3830/S. 1900: Bipartisan Congressional Trade Priorities Act of 2014
Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 21st Century Cures Initiative Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative
Renewable Chemicals/Bio-based Products S. 2260: EXPIRE Act of 2014Biofuels Accelerated Depreciation Extension Production Tax Credit Extension S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S. 193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 2260: EXPIRE Act of 2014 H.R. 4855, the PARTNER Act S. 1658: The Start-up Jobs and Innovation Act HR 4855: To amend the Internal Revenue Code of 1986 to provide an exception from the passive loss rules for investments in high technology research small business pass-thru entities Tax Reform Orphan Drug Act Tax Credit Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015
Clinical Trial Data Sharing and Disclosure Canadian Policies European PoliciesPatent Reform H.R. 2024: End Anonymous Patents Act H.R. 3309: Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) Implementation of H.R. 1249: The America Invents Act of 2011 FTC Regulation of Patent Demand Letters (Senator Commerce Committee Discussion Draft) World Trade Organization Special 301 Submissions TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Trade Promotion Authority H.R. 3830/S. 1900: Bipartisan Congressional Trade Priorities Act of 2014 Patenting of Biological Inventions PTO Examination Guidelines DNA Patenting and Licensing
21st Century Cures Initiative Patient Access to Approved DrugsReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes
USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech ProductsGenetically Engineered (GE) Animals H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Biosimilars Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Sunshine Act Implementation
Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations21st Century Cures Initiative Biomarkers and Regulatory Science Improvements Communication with Healthcare Professionals Expanded Access to Investigational Drugs Expedited Pathways FDA Hiring Flexibility FDA Management and Financial Accountability Innovation Incentives Longitudinal Study of Chronic Diseases Patient Access to Approved Drugs Patient-Focused Drug Development Use of Real-World Evidence Vaccine and Anti-Microbial Resistance Product Development and Incentives Combating Antibiotic-Resistant Bacteria (CARB) Initiative Biosimilars Biosimilar User Fee Act Implementation Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming Patent Certification Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 340B Drug Pricing Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Implementation of Affordable Care Act Program Implementation & Oversight Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Issues Intellectual Property IssuesReimbursement for Innovative Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure Canadian Policies European Policies Sunshine Act Implementation
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015Funding for FDA H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for National Institutes of Health H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Energy Basic Research Funding H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015 Funding for Biofuels H.R. 83: Consolidated and Further Continuing Appropriations Act for FY 2015
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR), White House Office
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · third_quarter · Q3
Funding for the USDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biofuels H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Implementation of the Agricultural Act of 2014 H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R.4923: Energy and Water Development and Related Agencies Appropriations Act for FY 2015
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · second_quarter · Q2
Trade Promotion Authority S.1900/H.R. 3830: Bipartisan Congressional Trade Priorities Act of 2014Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Intellectual Property International Enforcement Compulsory Licensing India Issues Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Sanitary and Phytosantiary Issues International Trade Commission Reform Transatlantic Trade and Investment Partnership Intellectual Property Issues Ag-Biotech Issues Regulatory Harmonization/Transparency Biosimilars Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure EU Policies
Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014Independent Payment Advisory Board Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2014 · first_quarter · Q1
Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Genetically Engineered (GE) Animals Labeling Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2015 FDA Approval H.R. 3547: Consolidated Appropriations Act for FY 2014 Review and Labeling of Food Derived From Biotechnology House Energy and Commerce Discussion Draft U.S. Government Policy Drug Evaluation and Review Special Medical Use/Limited Population Drug Implementation of the FDA Safety and Innovation Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 FDA Proposed Rule on Changes to Drug Labeling Biosimilars Naming Biosimilar User Fee Act Implementation Interchangeability and Pharmacy Substitution Colombia Biologics Regulations Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement Coexistence of Production Systems Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sunshine Act Implementation
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · third_quarter · 3A
Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · fourth_quarter · 4A
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act FY 2014 HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Energy Basic Research Funding DOE Office of Science Advanced Research Projects Agency - Energy Energy and Water Development and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.J. Res. 59: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding of Advanced Biofuels H.J. Res. 59: The Bipartisan Budget Act of 2013 Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · fourth_quarter · Q4
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Regulatory Harmonization Ag-Biotech Issues Intellectual Property Issues Biosimilars Colombia Biologics Regulations Naming Trade Promotion Authority Clinical Trial Data Sharing and Disclosure EU Policies
Biofuels Production Tax Credit Extension Accelerated Depreciation Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms Extension Permanency H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities H.R.3757: The Igniting American Research Act The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft), The Start-up Innovation Credit Act (Senator Coons Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Tax Reform Orphan Drug Act Tax Credit
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · third_quarter · Q3
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · second_quarter · Q2
Biofuels Production Tax Credit ExtensionTax Reform Renewable Chemicals/Bio-based Products Expansion of Advanced Manufacturing Investment Tax Credit to Renewable Chemicals and Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals S. 1267: Qualifying Renewable Chemical Production Tax Credit Act of 2013 H.R. 1696/S. 795: Master Limited Partnerships Parity Act Vaccine Access/Financing Tax on Seasonal Influenza Vaccine H.R. 425/S.391: A Bill To Amend the Internal Revenue Code of 1986 to Include Vaccines Against Seasonal Influenza Within the Definition of Taxable Vaccines Capital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules Research & Development Tax Credit Extension Orphan Drug Tax Credit
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Regulatory Review of Animal Pharmaceuticals S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2013 · first_quarter · Q1
Reimbursement for Innovative Products Medicare Part D Prescription Drug ProgramReimbursement for Innovative Products Cont. Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013
Livestock Cloning/Project Labeling Discussions with EU on Animal CloningUSDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Reviews of Biotech Products Genetically Engineered (GE) Animals FDA Approval Labeling Amendment to Restrict FDA Approval of GE Salmon Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S. Con. Res. 8: Senate Budget Resolution Generic Drug Patent Settlements S. Con. Res. 8: Senate Budget Resolution Labeling of Genetically Engineered Crops Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · fourth_quarter · 4A
Biodefense Research, Development, and Procurement (Non-Funding Issues) HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Labeling of Genetically Engineered Crops U.S. Government Policy
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · fourth_quarter · Q4
Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Vaccine Access/Financing Federal Response to the Rising Rates of Autism Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · third_quarter · 3A
Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · third_quarter · Q3
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency International Trade Commission Reform Rep. David Nunes Discussion Draft Intellectual Property International Enforcement Biosimilars Colombia Biologics Regulations Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals
BIOTECHNOLOGY INNOVATION ORGANIZATION via BIOTECHNOLOGY INNOVATION ORGANIZATION
2012 · second_quarter · Q2
Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program
Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program
Bonus Depreciation S. 2260: EXPIRE Act of 2014Tax Reform Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products Bonus Depreciation for Renewable Chemical Facilities S. 2260: EXPIRE Act of 2014 Biofuels Accelerated Depreciation Extension Production Tax Credit Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013 S. 2260: EXPIRE Act of 2014 Research & Development Tax Credit Reforms Extension Permanency H.R. 4438: American Research & Competitiveness Act of 2014 S. 2260: EXPIRE Act of 2014 S. 2715: The COMPETE Act S.193: The Start-up Innovation Credit Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 4855: The PARTNER Act S. 1658: The Start-up Jobs and Innovation Act S. 2715: The COMPETE Act Controlled Foreign Corporation Look-Through Rule Extension S. 2260: EXPIRE Act of 2014 Inversions H.R.4870: Department of Defense Appropriations Act for FY 2015 H.R.5016: Financial Services and General Government Appropriations Act for FY 2015
Sunshine Act Implementation 21st Century Cures InitiativeGenetically Engineered (GE) Animals FDA Approval H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Review and Labeling of Food Derived From Biotechnology H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Compassionate Use/Expanded Access Implementation of the FDA Safety and Innovation Act Special Medical Use/Limited Population Drug Biosimilars Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Naming USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 21st Century Cures Initiative
Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564/S. 1526: The Audit Integrity and Job Protection ActCapital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules S. 1658: The Start-up Jobs and Innovation Act H.R. 4855: The PARTNER Act S.2715: The COMPETE Act Expansion of Exemption under SEC Regulation A H.R. 4565: Startup Capital Modernization Act Proposed SEC Rule on Reg A+ Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: The Fostering Innovation Act XBRL Exemption for Small Public Companies H.R. 4164: Small Company Disclosure Simplification Act H.R. 5405: The Promoting Job Creation and Reducing Small Business Burdens Act Stock Exchange Tick Size H.R. 3448: The Small Cap Liquidity Reform Act H.R. 1952: The Spread Pricing Liquidity Act Capital Market Enhancements H.R. 3623: Improving Access to Capital for Emerging Growth Companies Act H.R. 4568: Small Business Freedom to Grow Act H.R. 4569: Disclosure Modernization and Simplification Act H.R. 4571: To direct the SEC to revise its rules so as to increase the threshold amount for requiring issuers to provide certain disclosures relating to compensatory benefits plans H.R. 4697: To require the SEC to revise the definition of a WKSI to reduce the worldwide market value threshold under the definition
Intellectual Property International Enforcement Compulsory Licensing IndiaForeign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Like-minded Countries Initiatives TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Transatlantic Trade and Investment Partnership Ag-Biotech Issues Intellectual Property Issues Regulatory Harmonization Reimbursement Transparency Biosimilars Colombia Biologics Regulations Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies
Patenting of Humanitarian Technologies S. 712: Patents for Humanity Program Improvement Act of 2013Patent Reform H.R. 3309: Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) FTC Regulation of Patent Demand Letters (Senate Commerce Committee Discussion Draft) Intellectual Property International Enforcement Compulsory Licensing India Issues TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Patenting of Biological Inventions
21st Century Cures Initiative Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program: CMS Proposed Rule on Protected Classes
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Naming Colombia Biologics Regulations Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Implementation of Affordable Care Act S.2694: Ensuring Access to Primary Care for Women and Children Act 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for FDA H.R. 4800/S.2389: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Sequestration of PDUFA Fees S. 1413: FDA User Fee Protection Act Drug Evaluation and Review Compassionate Use/Expanded Access Special Medical Use/Limited Population Drug Implementation of the FDA Safety and Innovation Act Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Canadian Policies Sunshine Act Implementation Affordable Care Act Implementation Third Party Support of Patient Premiums and Cost-Sharing Obligations 21st Century Cures InitiativeTransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Regulatory Harmonization Reimbursement Transparency Intellectual Property Issues
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Vaccine Access/Financing Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Implementation of Affordable Care Act Program Implementation & Oversight Departments of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Medicaid Pricing and Rebates Implementation of Affordable Care Act H.R. 1416: The Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) (Non-Funding) Program Implementation Sequestration of PDUFA Fees Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade & Investment Partnership Regulatory Harmonization/TransparencyDrug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Orphan Drug Act Tax Credit Clinical Trial Data Sharing and Disclosure EU Policies Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act
Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Funding for USDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 Funding for Biomass Crop Assistance Program Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Renewable Chemicals/Bio-based Products Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products Funding for Biofuels Department of Defense Funding of Advanced Biofuels Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Department of Defense Appropriations Act for FY 2015 Department of Interior, Environment, and Related Agencies Appropriations for FY 2015 Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biorefineries Department of Defense Funding of Advanced Biofuels Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Energy and Water Development and Related Agencies Appropriations Act for FY 2015
TransPacific Partnership Data and Intellectual Property Protections for PharmaceuticalsPatent Reform H.R. 3309: Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Targeting Rogue and Opaque Letters (TROL) Act of 2014 (Discussion Draft) FTC Regulation of Patent Demand Letters (Senate Commerce Committee Discussion Draft) Drug Repurposing H.R. 4287/S.2150: Independent Innovator and Repurposing Act Intellectual Property International Enforcement Compulsory Licensing India Issues Transatlantic Trade and Investment Partnership Intellectual Property Issues Patenting of Biological Inventions DNA Patenting and Licensing International Trade Commission Reform
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015Genetically Engineered (GE) Animals Labeling GE Animal Models of Human Disease FDA Approval Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Amendment on GE Salmon Labeling Amendment to Restrict FDA Approval of GE Salmon Drug Importation H.R. 4660: Commerce, Justice, Science and Related Agencies Appropriations Act for FY 2015 Review and Labeling of Food Derived From Biotechnology Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 4432: Safe and Accurate Food Labeling Act Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Drug Evaluation and Review Implementation of the FDA Safety and Innovation Act 21st Century Cures Initiative Compassionate Use/Expanded Access FDA Proposed Rule on Changes to Drug Labeling Special Medical Use/Limited Population Drugs H.R. 4475: Compassionate Freedom of Choice Act H.R. 2090: The Patient Choice Act H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Biosimilars Colombia Biologics Regulations Naming Implementation of Affordable Care Act Interchangeability and Pharmacy Substitution USDA/APHIS Agricultural Biotechnology Regulations Coexistence of Production Systems Efficient Science-Based Review of Biotech Products Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2015 Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Compounding Sunshine Act Implementation
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Biosimilars Naming Biosimilar User Fee Act Implementation Interchangeability and Pharmacy Substitution Colombia Biologics Regulations Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Reimbursement for Innovative Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Medicare Part B Physician-Administered Products H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Program Implementation Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.R. 3547: Consolidated Appropriations Act for FY 2014 Drug Repurposing H.R. 4287/2150: Independent Innovator and Repurposing Act Transatlantic Trade and Investment Partnership Reimbursement Transparency Intellectual Property Issues Regulatory HarmonizationTransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act FDA Proposed Rule on Changes to Drug Labeling Orphan Drug Act Tax Credit Drug Manufacturing, Quality & Distribution Implementation of H.R. 3204: The Drug Quality and Security Act Sunshine Act Implementation Medicare Physician Payment Sustainable Growth Rate Formula HR 4302: Protecting Access to Medicare Act of 2014 S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2000: SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 2122: Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 Clinical Trial Data Sharing and Disclosure EU Policies
Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform S. 866: Patent Quality Improvement Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 H.R. 3309: The Innovation Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 FTC Regulation of Patent Demand Letters (Senator McCaskill Discussion Draft) World Trade Organization Special 301 Submissions Intellectual Property International Enforcement Compulsory Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Drug Repurposing H.R. 4287/2150: Independent Innovator and Repurposing Act
Review and Labeling of Food Derived From Biotechnology House Energy and Commerce Discussion Draft U.S. Government PolicyEPA Regulations on Agricultural Biotechnology Efficient Science-Based Review of Biotech Products Herbicide Label Changes Insect Resistance Management Department of Interior, Environment, and Related Agencies Appropriations Act for FY 2015 Genetically Engineered (GE) Animals Labeling Agriculture, Rural Development, FDA, and Related Appropriations Act for 2015 FDA Approval H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for USDA H.R. 3547: Consolidated Appropriations Act for FY 2014 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations Korea Biotechnology Regulations Funding for Biotechnology Research and Development Programs at the Agency for International Development and Department of State H.R. 3547: Consolidated Appropriations Act for FY 2014 Biomass Programs Reauthorization of Biomass Crop Assistance Program Reauthorization of Biomass R&D Program S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement Coexistence of Production Systems Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Trans Pacific Partnership Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Ag-Biotech Issues
Funding for FDA Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Funding for USDA H.R. 3547: Consolidated Appropriations Act for FY 2014 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Biomass Crop Assistance Program Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2015 Sequestration of PDUFA Fees HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.R. 3547: Consolidated Appropriations Act for FY 2014 Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Funding for Biofuels Department of Defense Funding of Advanced Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2015 Department of Defense Appropriations Act for FY 2015 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2015 Department of the Interior, Environment, and Related Agencies Appropriations for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 Funding for Biorefineries S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) H.R. 2642: Agricultural Act of 2014 (Farm Bill) Funding for Biotechnology Research and Development Programs and the Agency for International Development and Department of State H.R. 3547: Consolidated Appropriations Act for FY 2014
Review and Labeling of Food Derived From Biotechnology House Energy and Commerce Discussion Draft U.S. Government PolicyGenetically Engineered (GE) Animals Labeling Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2015 FDA Approval H.R. 3547: Consolidated Appropriations Act for FY 2014
Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part D Prescription Drug Program CMS Proposed Rule on Protected Classes Medicare Part B Physician-Administered Products H.R. 1416: Cancer Patient Protection Act of 2013 Medicare Physician Payment Sustainable Growth Rate Formula HR 4302: Protecting Access to Medicare Act of 2014 S. 2110: Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014 S. 2000: SGR Repeal and Medicare Provider Payment Modernization Act of 2014 S. 2122: Responsible Medicare SGR Repeal and Beneficiary Access Improvement Act of 2014
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2015 H.R. 3547: Consolidated Appropriations Act for FY 2014 National Center for Advancing Translational Science (NCATS) Program Implementation
Genetically Engineered (GE) Animals Labeling Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2015 FDA ApprovalGenetically Engineered (GE) Animals Cont... H.R. 3547: Consolidated Appropriations Act for FY 2014
Filing targets: Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)
Labeling of Genetically Engineered Crops U.S. Government Policy S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on GE Crop Field Trials/Compensation Fund S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act
Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.J. Res 59: Continuing Appropriations Act for FY 2014
Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionRenewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Research & Development Tax Credit Reforms Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Tax Reform Orphan Drug Act Issues Tax Credit
Stock Exchange Tick Size Tick Size Flexibility Act (Rep. Duffy Discussion Draft) H.R. 1952: The Spread Pricing Liquidity ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Rep. McHenry Discussion Draft Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: Fostering Innovation Act Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies
Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 House Judiciary Committee Discussion Draft DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Asia Pacific Economic Cooperation Forum Biologics Regulations Export Registrations for Products With Expired Patents Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing
Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 National Center for Advancing Translational Science (NCATS) Funding Program Implementation
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Biofuels Production Tax Credit Extension Accelerated Depreciation Extension H.R. 3758: Second Generation Biofuel Extension Act of 2013Renewable Chemicals/Bio-based Products Investment Tax Credit for Renewable Chemicals and Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Master Limited Partnerships to Renewable Chemicals H.R. 1696/S. 795: Master Limited Partnerships Parity Act S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms Extension Permanency H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities H.R.3757: The Igniting American Research Act The Innovative Research and Competitiveness Act (Senator Carper Discussion Draft), The Start-up Innovation Credit Act (Senator Coons Discussion Draft) Capital Formation Investment Incentives Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules S. 1658: The Start-up Jobs and Innovation Act Tax Reform Orphan Drug Act Tax Credit
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningIntellectual Property International Enforcement Foreign Agricultural Biotechnology Laws and Regulations China Biotechnology Regulations Asynchrony of International Approvals Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Regulatory Transparency Data and Intellectual Property Protections for Pharmaceuticals Sanitary and Phytosanitary Issues Transatlantic Trade and Investment Partnership Regulatory Harmonization Ag-Biotech Issues Intellectual Property Issues Biosimilars Colombia Biologics Regulations Naming Trade Promotion Authority Clinical Trial Data Sharing and Disclosure EU Policies
Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research
Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act Biosimilars Naming Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Implementation of Affordable Care Act Drug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality and Security Act USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products
Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform House Judiciary Committee Discussion Draft (Rep. Bob Goodlatte) H.R. 3309: The Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Implementation of H.R. 1249: The America Invents Act of 2011 Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Genetic Resource Patent Disclosure Requirement World Intellectual Property OrganizationPatent Reform House Judiciary Committee Discussion Draft (Rep. Bob Goodlatte) H.R. 3309: The Innovation Act of 2013 H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 1720: Patent Transparency and Improvements Act of 2013 S. 866: Patent Quality Improvement Act of 2013 Implementation of H.R. 1249: The America Invents Act of 2011 Intellectual Property International Enforcement TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) H.J. Res. 59: The Bipartisan Budget Act of 2013 Amendment on GE Salmon Labeling Labeling of Food Derived From Biotechnology S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 U.S. Government Policy Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of the FDA Safety and Innovation Act Biosimilars Naming Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Implementation of Affordable Care Act Drug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality and Security Act USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products
Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Colombia Biologics Regulations Interchangeability and Pharmacy Substitution Naming Implementation of Affordable Care Act Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Vaccine Injury Compensation Program Adult Immunization (Senate Discussion Draft) 340B Drug Pricing Program Program Implementation & Oversight Implementation of Affordable Care Act S. 1284: Department of Labor, HHS, Education and Related Agencies Appropriations Act for FY 2014 Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Biodefense Research, Development and Procurement Issues Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013 Sequestration of PDUFA Fees H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act for FY 2014 HR 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 Implementation of S. 365: Budget Control Act S. 1413: FDA User Fee Protection Act Transatlantic Trade and Investment Partnership Regulatory Harmonization Intellectual Property Issues Drug Evaluation and Review Special Medical Use/Limited Population Drug H.R. 3742: Antibiotic Development to Advance Patient Treatment Act of 2013 Implementation of FDA Safety and Innovation Act Orphan Drug Act Tax CreditDrug Manufacturing, Quality & Distribution Supply Chain Integrity Pharmacy Compounding & Oversight Drug Shortages H.R. 3204: The Drug Quality & Security Act Clinical Trial Data Sharing and Disclosure EU Policies TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Coordination of Federal Biotechnology Research
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013Funding for FDA H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res. 59: The Bipartisan Budget Act of 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 2410/S. 1244: Agriculture, Rural Development, FDA and Related Agencies Appropriations Act FY 2014 HR 2725: Food and Drug Administration Safety over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act Energy Basic Research Funding DOE Office of Science Advanced Research Projects Agency - Energy Energy and Water Development and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.J. Res. 59: Bipartisan Budget Act of 2013 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding of Advanced Biofuels H.J. Res. 59: The Bipartisan Budget Act of 2013 Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.J. Res. 59: The Bipartisan Budget Act of 2013 H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill)
Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Senate Finance Committee Discussion Draft H.R. 1416: Cancer Patient Protection Act of 2013
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 National Center for Advancing Translational Science (NCATS) Funding Program Implementation
Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013
Vaccine Access/Financing Adult Immunization (Senate Discussion Draft)Biosimilars Colombia Biologics Regulations Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Interchangeability and Pharmacy Substitution Funding for National Institutes of Health S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act S.1284: Department of Labor, HHS, Education, and Related Agencies Appropriations Act of 2014 Expanded Access to Experimental Products FDA Rules Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 Independent Payment Advisory Board S.351/H.R. 351: Protecting Seniors' Access to Medicare Act of 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Harmonization Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program H.R. 1416: Cancer Patient Protection Act of 2013 National Center for Advancing Translational Science (NCATS) Funding Program Implementation Asia Pacific Economic Cooperation Forum Biologics RegulationTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and related agencies Appropriations Act FY 2014 H.R. 2725: Food and Drug Administration Safety Over Sequestration Act of 2013 S. 1413: FDA User Fee Protection Act H.J. Res 59: Continuing Appropriations Act for FY 2014 Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act Orphan Drug Act Issues Tax Credit Clinical Trial Data Sharing
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 1284: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.J. Res 59: Continuing Appropriations Act for FY 2014
Stock Exchange Tick Size Tick Size Flexibility Act (Rep. Duffy Discussion Draft) H.R. 1952: The Spread Pricing Liquidity ActSarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act S. 1526: The Audit Integrity and Job Protection Act Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Reform of SEC Regulation D Implementation of Jumpstart Our Business Start-ups (JOBS) Act Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action Rep. McHenry Discussion Draft Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions H.R. 2629: Fostering Innovation Act Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies
Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 House Judiciary Committee Discussion Draft DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Asia Pacific Economic Cooperation Forum Biologics Regulations Export Registrations for Products With Expired Patents Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization Clinical Trial Data Sharing
Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionRenewable Chemicals/Bio-based Products Expansion of Master Limited Partnerships to Renewable Chemicals New Production Tax Credit for Renewable Chemicals S. 1267/H.R. 3084: Renewable Chemical Production Tax Credit Act H.R. 1696/S. 795: Master Limited Partnerships Parity Act Research & Development Tax Credit Reforms Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) H.R.119: To amend the Internal Revenue Code to make permanent the credit for increasing research activities Capital Formation Investment Incentives Reform of Capital Gains Rules Reform of Net Operating Loss Rules Reform of Passive Loss Rules H.R. 6559/S.3595: High Technology Small Business Research Incentives Act Tax Reform Orphan Drug Act Issues Tax Credit
Labeling of Genetically Engineered Crops U.S. Government Policy S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on GE Crop Field Trials/Compensation Fund S.954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for FY 2014 Amendment on GE Salmon Labeling (Senate) Drug Safety and Review PDUFA V Implementation FDA Safety and Innovation Act Implementation Supply Chain Integrity Special Medical Use/Limited Population Drugs Pharmacy Compounding S. 957: Drug Supply Chain Security Act, S.959: Pharmaceutical Compounding Quality Act H.R. 1919: The Safeguarding America Pharmaceuticals Act
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Colombia Biologics Regulations Mexico Biologics Regulations Naming Health Regulatory Agency Review of Patents Brazil Colombia Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Vaccine Access/Financing Adult Immunization (Senate Discussion Draft) Tax on Seasonal Influenza Vaccine H.R. 425/S.391: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines Against Seasonal Influenza Within the Definition of Taxable Vaccines 340B Drug Pricing Program Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act HRSA Implementation of Program Changes Drug Safety and Review Supply Chain Integrity Pharmacy Compounding HR. 1919: The Safeguarding Americas Pharmaceuticals Act S. 957: Drug Supply Chain Security Act S. 959: Pharmaceutical Compounding Quality Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act Asia Pacific Economic Cooperation Forum Intellectual Property Issues Biologics RegulationsTransatlantic Trade and Investment Partnership Intellectual Property Issues Regulatory Harmonization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Orphan Drug Tax Credit
Independent Payment Advisory BoardReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program
Intellectual Property International Enforcement Compulsory LicensingPatent Reform Implementation of H.R. 1249: The America Invents Act of 2011 House Judiciary Committee Discussion Draft H.R. 2024: End Anonymous Patents Act H.R. 845: The SHIELD Act of 2013 S. 1013: Patent Abuse Reduction Act of 2013 S. 866: Patent Quality Improvement Act of 2013 DNA Patenting and Licensing TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Transatlantic Trade and Investment Partnership Intellectual Property Issues Health Regulatory Agency Review of Patents Brazil Colombia Asia Pacific Economic Cooperation Forum Intellectual Property Issues Drug Patent Settlements
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Labeling of Genetically Engineered Crops U.S. Government Policy H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendments on GE Food Labeling S.1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningUSDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on Weed Resistance Amendment on GE Crop Field Trials/Compensation Fund S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendment on Farmer Assurance Genetically Engineered (GE) Animals Labeling S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Labeling of Genetically Engineered Crops U.S. Government Policy H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendments on GE Food Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Drug Safety and Review Supply Chain Integrity Pharmacy Compounding HR. 1919: The Safeguarding Americas Pharmaceuticals Act S. 957: Drug Supply Chain Security Act S. 959: Pharmaceutical Compounding Quality Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Biofuels Department of Defense Funding/Application of Advanced Biofuels Energy and Water Development and Related Agencies Appropriations Act for FY 2014 H.R. 2397: Department of Defense Appropriations Act for FY 2014 Funding for Biorefineries Reauthorization/Funding of Biorefinery Grant and Loan Programs H.R. 1960/S. 1034: National Defense Authorization Act for FY 2014 H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for Biomass Crop Assistance Program S. 1244/ H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act Energy Basic Research Funding Energy and Water Development and Related Agencies Appropriations Act for FY 2014
TransPacific Partnership Sanitary and Phytosanitary IssuesUSDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products USDA Decision on GE Crops Environmental Impact Statement H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) Amendment on Weed Resistance Amendment on GE Crop Field Trials/Compensation Fund S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendment on Farmer Assurance EPA Regulations on Agricultural Biotechnology Reauthorization and Implementation of Pesticide Registration Improvement Act Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals Labeling S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Appropriations Act for 2014 Amendment on GE Salmon Labeling (Senate) S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 Labeling of Genetically Engineered Crops U.S. Government Policy H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Amendments on GE Food Labeling S. 1244/H.R. 2410: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) H.R. 2410/S. 1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations EU Biotechnology Bilateral Discussions Low-Level Presence Foreign Government Policies Agricultural Biotechnology Regulatory Reform and Modernization S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Benefits of Ag-Biotech Research and Innovation H.R. 1947: Federal Agriculture Reform and Risk Management Act of 2013 (Farm Bill) S. 954: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 2410/S.1244: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Regulatory Review of Animal Pharmaceuticals S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013Transatlantic Trade and Investment Partnership Ag-Biotech Issues
Reform of SEC Regulation D Implementation of H.R. 3606: Jumpstart Our Business Start-ups (JOBS) ActCapital Formation Investment Incentives H.R. 6599/S.3595: High Technology Small Business Research Incentives Act Reform of Passive Loss Rules Reform of Net Operating Loss Rules Reform of Capital Gains Rules Expansion of Exemption Under SEC Regulation A H.R. 701: To amend a provision of the Securities Act of 1933 directing the Securities and Exchange Commission to add a particular class of securities to those exempted under such Act to provide a deadline for such action. Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions Fostering Innovation Act (Rep. Fitzpatrick Discussion Draft) Market Structure Reform for Small Companies XBRL Exemption for Small Public Companies Sarbanes Oxley Section 404 (b) Mandatory Audit Firm Rotation H.R. 1564: The Audit Integrity and Job Protection Act Stock Exchange Tick Size H.R. 1952: The Spread Pricing Liquidity Act Tick Size Flexibility Act (Rep. Duffy Discussion Draft)
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for Renewable Chemicals/Bio-based Products Expansion of Biorefinery Assistance Program to Renewable Chemicals and Bio-based Products Reauthorization/Funding of USDA Bio-Preferred Program S.10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for Biofuels Department of Defense Funding/Application of Advanced Biofuels Department of Defense Appropriations Act for FY 2014 Department of Energy and Water and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 (Toomey Amendment) Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Funding for Biomass Programs H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Reauthorization/Funding of Biomass Crop Assistance Program Reauthorization/Funding of Biomass R&D Program S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biorefineries Reauthorization/Funding of Biorefinery Assistance Program DOE Biomass Program Department of Defense Funding S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 (Toomey Amendment) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. Con. Res. 8: Senate Budget Resolution
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization ActBiodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act
USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Reviews of Biotech ProductsLivestock Cloning/Product Labeling Discussions with EU on Animal Cloning EPA Regulations on Agricultural Biotechnology Genetically Engineered (GE) Animals FDA Approval Amendment to Restrict FDA Approval of GE Salmon Labeling Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S. Con. Res. 8: Senate Budget Resolution Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy S. 10: Agriculture Reform, Food, and Jobs Act of 2013 S (Farm Bill) Foreign Agricultural Biotechnology Laws and Regulations Asynchrony of International Approvals China Biotechnology Regulations International Biotechnology Agreement EU Biotechnology Bilateral Discussions Low-Level Presence Foreign Government Policies Agricultural Biotechnology Regulatory Reform and Modernization S. 10: Agriculture Reform, Food, and Jobs Act of 2013 (Farm Bill) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Benefits of Ag-Biotech Research and Innovation Regulatory Review of Animal Pharmaceuticals S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 TransPacific Partnership Sanitary and Phytosanitary Issues
Patent Reform LitigationTransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl World Trade Organization Special 301 Submissions Generic Drug Patent Settlements S. Con. Res. 8: Senate Budget Resolution Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Intellectual Property International Enforcement Compulsory Licensing International Patent Law Harmonization Patent Exhaustion
Livestock Cloning/Project Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals FDA Approval Labeling Amendment to Restrict FDA Approval of GE Salmon Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S. Con. Res. 8: Senate Budget Resolution Labeling of Genetically Engineered Crops Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013
Biofuels Production Tax Credit Extension Accelerated Depreciation ExtensionResearch & Development Tax Credit Extension Startup Innovation Credit (Senator Coons Discussion Draft) Innovative Research and Competitiveness Act (Senator Carper Discussion Draft) Capital Formation Investment Incentives High Technology Small Business Research Incentives Act (Discussion Draft) Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S.391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Tax Reform Renewable Chemicals/Bio-based Products New Production Tax Credit for Renewable Chemicals Expansion of Advanced Manufacturing Investment Tax Credit to Renewable Chemicals and Bio-Based Products Expansion of Master Limited Partnerships to Renewable Chemicals
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling FDA Approval Amendment to Restrict FDA Approval of GE Salmon Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 S. Con. Res. 8: Senate Budget Resolution Regulatory Review of Animal Pharmaceuticals S. 622: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
Funding for National Institutes of Health H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014Funding for Centers for Disease Control and Prevention Vaccine Programs Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Vaccine Access/Financing Tax for Seasonal Influenza Funding H.R. 425/S. 391: A bill to amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines Adult Immunization Policies Adult Immunization Senate Discussion Draft 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Drug Safety and Review Implementation of S. 3187: The Food and Drug Administration Safety and Innovation Act Regulatory Reforms for Innovative Products Expedited Approval Pathways E-Pedigree and Anti-Counterfeiting Supply Chain Integrity Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Independent Payment Advisory Board Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products H.Con.Res. 25: House Budget Resolution (Democratic Caucus Substitute) H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 U.S./European Union High-Level Dialogue on Regulatory IssuesSequestration of PDUFA Fees H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 Implementation of S. 365: Budget Control Act TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuitcalsl Regulatory Transparency
Funding for National Institutes of Health Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 H.R. 933: Consolidated and Further Continuing Appropriations Act for FY 2013 H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act Cures Acceleration Network Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2014 Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Biodefense Research, Development, and Procurement (Non-Funding Issues) H.R. 307: Pandemic and All-Hazards Preparedness Reauthorization Act
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act
Patent Reform H.R. 6621: To correct and improve certain provisions of the Leahy-Smith America Invents ActIntellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Export Registrations for Products with Expired Patents
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningGenetically Engineered (GE) Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
Livestock Cloning/Product Labeling Discussions with EU on Animal CloningUSDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
EPA Regulations on Agricultural Biotechnology EPA Notice on PIP Data RequirementsUSDA/APHIS Agricultural Biotechnology Regulations S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Export Registrations for Products with Expired Patents Labeling of Genetically Engineered (GE) Crops U.S. Government Policy Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Agricultural Biotechnology Regulatory Reform and Modernization S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Potential Regulation of New Genetic Modification Technologies Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals Adventitious Presence (Low Level Presence)
Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013Vaccine Access/Financing Federal Response to the Rising Rates of Autism Tax for Seasonal Influenza Funding H.R. 6687/S.3716: A Bill to Amend the Internal Revenue Code of 1986 to Include Vaccines against Seasonal Influenza within the Definition of Taxable Vaccines 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act of 2010 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement S 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act Medicaid Rebates
Average Manufacturer Price Calculations Medicaid RebatesReimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013Biodefense Research, Development, and Procurement (Non-Funding Issues) S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development, and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement (Non-Funding Issues) S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 HHS Countermeasures Review
Patent Reform H.R. 6621: To correct and improve certain provisions of the Leahy-Smith America Invents Act Intellectual Property International Enforcement Compulsory Licensing Patient Revocations Indonesian Issues Indian Issues World Trade Organization Special 301 Submissions International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protections for Pharmaceuticals Export Registrations for Products with Expired Patents
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
EPA Regulations on Agricultural Biotechnology EPA Notice on PIP Data Requirements USDA/APHIS Agricultural Biotechnology Regulations S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Export Registrations for Products with Expired Patents Labeling of Genetically Engineered (GE) Crops U.S. Government Policy Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Agricultural Biotechnology Regulatory Reform and Modernization S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Potential Regulation of New Genetic Modification Technologies Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations Asynchrony of International Approvals Adventitious Presence (Low Level Presence)
Biodefense Research, Development, and Procurement (Non-Funding Issues) HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discuss Draft) Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act of 2012 Pharmacy Compounding Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for National Institutes of Health National Center for Advancing Translational Sciences (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of S. 365: Budget Control Act
Average Manufacturer Price Calculations Medicaid Rebates Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Labeling of Genetically Engineered Crops U.S. Government Policy
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office
Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act of 2012
EPA Regulations on Agricultural Biotechnology Reauthorization and Implementation of Pesticide Registration Improvement Act H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) USDA/APHIS Agricultural Biotechnology Regulations S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Biomass Crop Assistance Program Funding S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops U.S. Government Policy U.S. Policy on International Science-Based Regulations TransPacific Partnership Sanitary and Phytosanitary Issues Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Agricultural Biotechnology Regulatory Reform and Modernization S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Benefits of Ag-Biotech Research and Innovation S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Potential Regulation of New Genetic Modification Technologies Patent Exhaustion Ag-biotech Products Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Export Registrations for Products with Expired Patents U.S. Policy on International Science-Based Regulations Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Sanitary and Phytosanitary Issues Regulatory Transparency International Trade Commission Reform Rep. David Nunes Discussion Draft Intellectual Property International Enforcement Biosimilars Colombia Biologics Regulations Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft ) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Australia Compulsory Licensing Parliamentary Inquiry Confirmatory Genetic Diagnostic Testing Intellectual Property International Enforcement Patent Exhaustion Ag-biotech Products International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Patent Reform Implementation of the America Invents Act of 2011
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office
Bayh-Dole Act/Tech Transfer Commercialization of Federally Funded Research Initiative Genetic Resource Patent Disclosure Requirement World Intellectual Property Organization DNA Patenting and Licensing Australia Compulsory Licensing Parliamentary Inquiry Confirmatory Genetic Diagnostic Testing Intellectual Property International Enforcement Patent Exhaustion Ag-biotech Products International Trade Commission Reform Rep. Devin Nunes Discussion Draft TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Patent Reform Implementation of the America Invents Act of 2011
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops U.S. Government Policy
Pharmaceutical Industry Annual Fee Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Treasury and IRS Regulations Implementing the Law Biosimilars Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Colombia Biologics Regulations Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translations Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Taxable Vaccines Act (Discussion Draft) 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Average Manufacturer Price Calculations Therapeutic Discovery Project Tax Credit S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program Extension Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S.1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011 TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Reimbursement for Innovative Products Medicare Part D Prescription Drug Program Medicare Part B Physician-Administered Products Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development, and Procurement HHS Countermeasures Review S. 1855/H.R. 2405: Pandemic and All Hazards Preparedness Act Reauthorization of 2011
Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Funding for Bio-based Products S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Biofuels S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Funding for Biorefineries S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Centers for Disease Control and Prevention Vaccine Programs S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translational Science (NCATS) S.R. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Funding for Biomass Crop Assistance Program S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Funding for Renewable Chemicals S.R. 2465/H.R. 5325: Department of Energy and Water and Related Agencies Appropriations Act for FY 2013 S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Sequestration of PDUFA Fees Implementation of P.L. No: 112-25: Budget Control Act of 2012
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Reporting of Physician Payments Implementation of P.L. No: 111-148: Patient Protection and Affordable Care Act Labeling of Genetically Engineered Crops U.S. Government Policy Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Access to External Experts Conflicts of Interest Drug Shortages E-Pedigree and Anti-Counterfeiting (Sens. Michael Bennett/Richard Burr Discussion Draft ) Expedited Approval Pathways FDA Mission Regulatory Reforms for Innovative Products Supply Chain Integrity Implementation of P.L. No: 112-144: The Food and Drug Administration Safety and Innovation Act Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) (2) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013
EPA Regulations on Agricultural Biotechnology Reauthorization and Implementation of Pesticide Registration Improvement Act H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) USDA/APHIS Agricultural Biotechnology Regulations S.3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems Biomass Crop Assistance Program Funding S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered (GE) Animals FDA Approval Labeling S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops U.S. Government Policy U.S. Policy on International Science-Based Regulations TransPacific Partnership Sanitary and Phytosanitary Issues Funding for the USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Cartagena Biosafety Protocol U.S. Government Positions/Activities/Communications at Biosafety Protocol Meetings Agricultural Biotechnology Regulatory Reform and Modernization S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Benefits of Ag-Biotech Research and Innovation S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) H.R. 6083: Federal Agriculture Reform and Risk Management Act of 2012 (Farm Bill) Potential Regulation of New Genetic Modification Technologies Patent Exhaustion Ag-biotech Products Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies China Biotechnology Regulations International Biotechnology Agreement Asynchrony of International Approvals Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy
Filing targets: Agriculture, Dept of (USDA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), U.S. Trade Representative (USTR), White House Office
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon
EPA Regulations on Agricultural Biotechnology Departments of the Interior, Environment, and Related Agencies Appropriations Act for FY 2013 Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Biotechnology Stewardship Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Export Registrations for Products with Expired Patents Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food TransPacific Partnership Sanitary and Phytosanitary Issues Adventitious Presence (Low Level Presence) U.S. Low Level Presence Policy Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Funding for USDA (Office of General Counsel, Biotechnology Regulatory Services, National Institute of Food and Agriculture, APHIS, Trade Activities (Office of the Secretary & Food Safety Inspection Service), National Resources Conservation Service, Agriculture Research Service, Biofuels, Foreign Agriculture Service) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Foreign Agricultural Biotechnology Laws and Regulations Low-Level Presence Foreign Government Policies EU Biotechnology Bilateral Discussions China Biotechnology Regulations European Union Low Level Presence Policy International Biotechnology Agreement Asynchrony of International Approvals Agricultural Biotechnology Regulatory Reform and Modernization S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Benefits of Ag-Biotech Research and Innovation S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Patent Exhaustion Ag-biotech Products Potential Regulation of New Genetic Modification Technologies Biomass Crop Assistance Program Funding Renewal S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft)
Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act
Filing targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office