How to read the money
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.
Mobile Workforce State Income Tax Simplification Act of 2015
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
Mobile Workforce State Income Tax Simplification Act of 2015
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines . Trade Promotion Authority . Trans-pacific Partnership . Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Source: Senate LDA
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Promoting Life-Saving New Therapies for Neonates Act of 2016
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Promoting Life-Saving New Therapies for Neonates Act of 2016
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
Promoting Life-Saving New Therapies for Neonates Act of 2016
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Improving Regulatory Transparency for New Medical Therapies Act
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
Improving Regulatory Transparency for New Medical Therapies Act
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Improving Regulatory Transparency for New Medical Therapies Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Improving Regulatory Transparency for New Medical Therapies Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Improving Regulatory Transparency for New Medical Therapies Act
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
Promoting Life-Saving New Therapies for Neonates Act of 2015
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA
Improving Regulatory Transparency for New Medical Therapies Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA
Improving Regulatory Transparency for New Medical Therapies Act
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Biosimilars Medicare Part D Drug Pricing Part B CMMI Part B Demonstration Project Generics Innovative Pharmaceuticals
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines . Trade Promotion Authority . Trans-pacific Partnership . Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation
Biosimilars Medicare Part D Drug Pricing Part B CMMI Part B Demonstration Project Generics Innovative Pharmaceuticals
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Biosimilars Medicare Part D Drug Pricing Part B CMMI Part B Demonstration Project
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Columbia Intellectual Property
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015 Neonates
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
Biosimilars Medicare Part D Drug Pricing Part B
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Biosimilars Medicare Part D Drug Pricing Part B
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO S.1890 Defend Trade Secrets Act of 2016 H.R.3326 Defend Trade Secrets Act of 2015
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act
Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Biosimilars
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2015 Labor HHS Appropriations Bill
Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
H.R.3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual PropertyBiopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health IssuesIndia and Canada IP and Market Access Issues Trans-Pacific Partnership FTA Sub-Standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-Pacific Partnership - Trans Atlantic Trade and Investment Partnership HR 3830/S 1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill - FY 2014 Labor HHS Appropriations Bill
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation
Biosimilars Medicare Part D Drug Pricing
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2015 Labor HHS Appropriations Bill
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2015 Labor HHS Appropriations Bill
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
HR3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2015 Labor HHS Appropriations Bill
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
ACA Pharmaceutical Industry Fee Exclusions R&D Tax Credit Anti-Inversion Tax
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India and Canada IP and market Access Issues Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-pacific Partnership - Trans Atlantic Trade and Investment Partnership HR3830/S1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
S1128 Preserving Access to Orphan Drugs Act of 2013 H.R.2315 Preserving Access to Orphan Drugs Act of 2013 Anti-Inversion Tax Legislation R&D Tax Credit
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill - FY 2014 Labor HHS Appropriations Bill
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
H.R.3116 MODDERN Cures Act of 2013 Data Exclusivity Trade Secrets Intellectual PropertyBiopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Draft Legislation on Trade Secret Issues
S1128 Preserving Access to Orphan Drugs Act of 2013 H.R.2315 Preserving Access to Orphan Drugs Act of 2013 Anti-Inversion Tax Legislation R&D Tax Credit
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health IssuesIndia and Canada IP and Market Access Issues Trans-Pacific Partnership FTA Sub-Standards Medicines Quality of Medicines Global Intellectual Property Issues Including: - Trade Promotion Authority - Trans-Pacific Partnership - Trans Atlantic Trade and Investment Partnership HR 3830/S 1900 - Bipartisan Congressional Trade Priorities Act of 2014 International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)