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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Medicare Negotiation and Competitive Licensing Act of 2019
H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ACA Pharmaceutical Industry Fee Exclusions Orphan Drug Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Tax Cuts & Jobs Act Implementation Innovation Box Expended FDII
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Columbia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Source: Senate LDA
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
S.659 - Biologic Patent Transparency Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars
Speeding Access to Already Approved Pharmaceuticals Act of 2017
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Promoting Life-Saving New Therapies for Neonates Act of 2017
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Promoting Life-Saving New Therapies for Neonates Act of 2017
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Promoting Life-Saving New Therapies for Neonates Act of 2017
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Promoting Life-Saving New Therapies for Neonates Act of 2017
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Promoting Life-Saving New Therapies for Neonates Act of 2017
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Promoting Life-Saving New Therapies for Neonates Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher
Promoting Life-Saving New Therapies for Neonates Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Promoting Life-Saving New Therapies for Neonates Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher
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
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 - 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
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 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 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
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/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 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 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
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 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
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 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 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
H.R. 1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury
HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Clinical Trials Virtual Clinical Trials Part D Donut Hole Biosimilar Pass Through Payments Value Based Pricing
S.659 - Biologic Patent Transparency Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) Reconciliation Gx Drug Labeling Biosimilars Importation Drug Pricing Value of Meds
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
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2018 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2018 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation Innovation Box Expanded FDII
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO 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
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2018 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2018 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation Innovation Box Expanded FDII
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
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
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2017 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2017 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO 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
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation Innovation Box Expanded FDII
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO Biosimilars
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars 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 IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2018 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2018 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury
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
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2017 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2017 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS Tariffs CFIUS
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2017 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2017 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2017 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2017 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS
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 2017 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce
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 The North American Free Trade Agreement - NAFTA USTR Special 301 Report/National Trade Estimate
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
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
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
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
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
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling
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
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation
Biosimilars Medicare Part D Drug Pricing
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
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
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
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
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
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
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
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
S1128 Preserving Access to Orphan Drugs Act of 2013 H.R.2315 Preserving Access to Orphan Drugs Act of 2013
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
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
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines
Orphan Drug Tax Credit
Access to Life Saving Medicines Act 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 ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (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
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (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
Orphan Drug Tax Credit
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of VaccinesHR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Orphan Drug Tax Credit
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Free Trade Agreements: - Intellectual Property Provisions in Panama, Colombia, Korea Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (RREA) Drug Distribution Security (Track & Trace)
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Wage vs. Hour
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Wage vs. Hour
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program 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 Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction Debt Equity Regulations Tax Cuts & Jobs Act Implementation
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy Medicaid Alternative Payment Models
Foreign Investment Risk Review Modernization Act of 2017 (FIRMMA) CFIUS Reform Foreign Agents Registration Act (FARA) Reform Treasury
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO 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
Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
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 Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction
Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017
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 Outcomes Based Contracts Generics Innovative Pharmaceuticals
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher
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 Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy
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 Generics Innovative Pharmaceuticals
ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax
Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 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 IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017
FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2017 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), Veterans Affairs, Dept of (VA), White House Office
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
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
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
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
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
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
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
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
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
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)
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
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)
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
S1128 Preserving Access to Orphan Drugs Act of 2013 H.R.2315 Preserving Access to Orphan Drugs Act of 2013
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)
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
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)
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (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
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)
Orphan Drug Tax Credit
Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2013 - Labor HHS Appropriations Bill
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
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)
Free Trade Agreements: - Intellectual Property Provisions - Free Trade Agreements Access to Medicines Global Health IssuesIndia IP Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Orphan Drug Tax Credit
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)
Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (MIdical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices
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)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
Orphan Drug Tax Credit
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)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program S.1855, HR 2405 Pandemic and All-Hazards Preparedness Act Reauthorization of 2011
Filing targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)
Free Trade Agreements: - Intellectual Property Provisions Access to Medicines Global Health Issues/Global Pandemic Influenza Planning Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines
Orphan Drug Tax Credit
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) S 75 - Generics First Act 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 2182, S 1734 Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA (Medical Device User Fee Act) Reauthorization HR 452 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program HR 2245 - Drug Shortages Dual Eligibles Program HR 436, S 17 Medical Device Tax Repeal Reauthorization of Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (RREA) Drug Distribution Security (Track & Trace) HR 2672 Preserving Access to Orphan Drugs Act of 2011 S 1423 Preserving Access to Orphan Drugs Act of 2011 S. 3187 Food and Drug Administration Safety and Innovation Act Certified Importer Program
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)
Orphan Drug Tax Credit
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions FY 2013 - Labor HHS Appropriations Bill
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Wage vs. Hour
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)
Wage vs. Hour
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Orphan Drug Tax Credit
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
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)
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Orphan Drug Tax Credit
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)
Orphan Drug Tax Credit
HR 1458 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 S565 Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2009 Pandemic Influenza Funding FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) R 7110 Job Creation and Unemployment Relief Act of 2008 HR 1 American Recovery and Reinvetment Act FY 2011 - DOD Appropriations Bill 2011 Continuing Resolutions
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
H.R.1249 - America Invents Act S.23 - America Invents Act Patent Settlement Legislation - 2011
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)
HR 452 - Medicare Decisions Accountability Act of 2011 S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 Gene Therapy Personalized Medicine H.R.2245 Preserving Access to Life-Saving Medications Act of 2011 S.296 Preserving Access to Life-Saving Medications Act S.1206 Medicare Drug Savings Act of 2011 H.R.2190 Medicare Drug Savings Act of 2011 Section 9008 of Patient Protection and Affordable Care Act Prescription Drug User Fee Act (PDUFA) H.R.4872 Health Care and Education Reconciliation Act of 2010 S 75 - Generics First Act 2009 S 301 - Physician Payments Sunshine Act of 2009 H.R.759 Food and Drug Administration Globalization Act of 2009 HR 276 - Proper Disposal of Unused Pharmaceuticals S1213 Patient-Centered Outcomes Research Act of 2009 HR 4702, HR 4990 - A bill to amend title XIX of the Social Security Act to include all public clinics for the distribution of pediatric vaccines under the Medicaid program. HR 1259 Dextromethorphan Distribution Act of 2009 S 1383 Dextromethorphan Abuse Reduction Act of 2009 S 256 Combat Methamphetamine Enhancement Act of 2009 HR 2923 Combat Methamphetamine Enhancement Act of 2009 S.1232 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 1548 - To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 21st Century Cancer Bill Public Health Service Act Dextromethorphan - Age Restrictions - Controlling bulk shipments Pseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone Support incentives for development of new, innovative antibiotics (former GAIN Act) MDUFA
Wage vs. Hour
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)
Access to Life Saving Medicines Act Provide Medicare Part B Coverage for Vaccines Covered under Part D Medicaid Coverage of Vaccines HR2 Children's Health Insurance Program Reauthorization Act of 2009 S 275 Children's Health Insurance Program Reauthorization Act of 2009 HR 2800 Imported Food Safety Improvement Act of 2009 Medicare Prescription Drugs and Modernization Act Immunosuppressant Legislation
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)