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Reported covered position: Staff Assistant to Rep. Connie Mack (2009-2010)
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Affordable and Safe Prescription Drug Importation Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · second_quarter · Q2
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Source: Senate LDA
FAST Generics Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
CREATES Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
FDA Reauthorization Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Making Pharmaceutical Markets More Competitive Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Lower Drug Costs through Competition Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Lower Drug Costs through Competition Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Lower Drug Costs through Competition Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Making Pharmaceutical Markets More Competitive Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Preserve Access to Affordable Generics Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Affordable and Safe Prescription Drug Importation Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Improving Access To Affordable Prescription Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
FDA Reauthorization Act of 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Creating and Restoring Equal Access to Equivalent Samples Act of 2018
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
CREATES Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
CREATES Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
CREATES Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Fair Accountability and Innovative Research Drug Pricing Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. H.R.1314: Bipartisan Budget Act of 2015. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. H.R.1314: Bipartisan Budget Act of 2015. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Bipartisan Budget Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost,H.R. 2841 FAST Generics Act,The Bipartisan Budget Act of 2015, Drug Importation, Risk Evaluation and Mitigation Strategies(REMS),Biologics Price Competition and Innovation Act (BPCIA), Pharmaceutical exclusivity
FAST Generics Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost,H.R. 2841 FAST Generics Act,The Bipartisan Budget Act of 2015, Drug Importation, Risk Evaluation and Mitigation Strategies(REMS),Biologics Price Competition and Innovation Act (BPCIA), Pharmaceutical exclusivity
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Pharmaceutical Stewardship Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Pharmaceutical Stewardship Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Pharmaceutical Stewardship Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Pharmaceutical Stewardship Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Pharmaceutical Stewardship Act of 2016
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act. Generic and competition provision in the H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act. Generic and competition provision in the H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
21st Century Cures Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
Comprehensive Addiction and Recovery Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Comprehensive Addiction and Recovery Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Comprehensive Addiction and Recovery Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Comprehensive Addiction and Recovery Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Comprehensive Addiction and Recovery Act of 2015
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Increasing Competition in Pharmaceuticals Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · first_quarter · 1A
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Inter Partes Review (IPR) process. Patent Settlements.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. USTR Confirmation.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2017 · first_quarter · Q1
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. S.Con.Res.3: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018 through 2026.
Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. USTR Confirmation.
Inter Partes Review (IPR) process. Patent Settlements.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program.
Taxation Issues Related to Opioid Pharmaceuticals. User Fee Programs.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · fourth_quarter · 4A
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. CMMI Part B Drug Demo.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
Inter Partes Review (IPR) process. Patent Settlements.
Taxation Issues Related to Opioid Pharmaceuticals.
Filing targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · third_quarter · 3A
Inter Partes Review (IPR) process. Patent Settlements.
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act. Generic and competition provision in the H.R.6: 21st Century Cures Act.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
Trans-Pacific Partnership (TPP). Biologic Exclusivity.
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · second_quarter · 2A
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
Trans-Pacific Partnership (TPP). Biologic Exclusivity.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · first_quarter · 1A
Trans Pacific Partnership, Biologic Exclusivity
Medicare Part D Program and Generic Drugs,Medicare reimbursement for biosimilars, The Bipartisan Budget Act of 2015, Fiscal Year 2016 Omnibus Appropriations Act, Covered Outpatient Drugs (CMS-2345-FC)
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost,H.R. 2841 FAST Generics Act,The Bipartisan Budget Act of 2015, Drug Importation, Risk Evaluation and Mitigation Strategies(REMS),Biologics Price Competition and Innovation Act (BPCIA), Pharmaceutical exclusivity
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · third_quarter · 3A
Trans-Pacific Partnership (TPP). Biologic Exclusivity.
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · fourth_quarter · Q4
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). Pharmaceutical exclusivity. S.3056: CREATES Act of 2016. H.R.6: 21st Century Cures Act.
Inter Partes Review (IPR) process. Patent Settlements.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · third_quarter · Q3
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
Trans-Pacific Partnership (TPP). Biologic Exclusivity.
Inter Partes Review (IPR) process. Patent Settlements.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · second_quarter · Q2
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. H.R.1314: Bipartisan Budget Act of 2015. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2016 · first_quarter · Q1
Trans Pacific Partnership, Biologic Exclusivity
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost,H.R. 2841 FAST Generics Act,The Bipartisan Budget Act of 2015, Drug Importation, Risk Evaluation and Mitigation Strategies(REMS),Biologics Price Competition and Innovation Act (BPCIA), Pharmaceutical exclusivity
Medicare Part D Program and Generic Drugs,Medicare reimbursement for biosimilars, The Bipartisan Budget Act of 2015, Fiscal Year 2016 Omnibus Appropriations Act, Covered Outpatient Drugs (CMS-2345-FC)
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2015 · fourth_quarter · Q4
FDA Funding, H.R. 1078 FDA Safety Over Sequestration Act, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2016, The Bipartisan Budget Act of 2015, Fiscal Year 2016 Omnibus Appropriations Act
Trans-Pacific Partnership
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, Innovation for Healthier Americans Initiative, Prescription Drug Cost, H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, S. 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act, H.R. 2841 FAST Generics Act, Dormant Therapies Act, H.R. 3513 Prescription Drug Affordability Act, S. 2023 Prescription Drug Affordability Act, The Bipartisan Budget Act of 2015, Importation
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2015 · third_quarter · Q3
FDA Funding, H.R. 1078 FDA Safety Over Sequestration Act, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2016, Administration budget for Fiscal Year 2017
H.R. 9 The Innovation Act, S. 1137 PATENT Act, S. 2019 Preserve Access to Affordable Generics Act
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, H.R. 6 21st Century Cures Act, Innovation for Healthier Americans Initiative, Prescription Drug Pricing, H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, S. 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act, H.R. 2841 FAST Generics Act, Dormant Therapies Act, H.R. 3513 Prescription Drug Affordability Act, S. 2023 Prescription Drug Affordability Act
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2015 · second_quarter · Q2
FDA Funding, H.R. 1078 FDA Safety Over Sequestration Act, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2016
Medicare Part D Program and Generic Drugs,H.R. 2391 Medicaid Generic Drug Price Fairness Act, S. 1364 Medicaid Generic Drug Price Fairness Act
Implementation of FDASIA and GDUFA,Labeling of Generic Drugs, Biosimilars Naming, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, H.R. 6 21st Century Cures Act, Innovation for Healthier Americans Initiative, Prescription Drug Pricing, Abuse-Deterrent Prescription Drug Formulations,H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, S. 1421 Orphan Product Extensions Now Accelerating Cures and Treatments Act,H.R. 2841 FAST Generics Act
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2015 · first_quarter · Q1
Implementation of FDASIA and GDUFA, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation and Mitigation Strategies, Biosimilars Naming, Electronic Labeling for Pharmaceuticals, Issues Regarding Market Exclusivity, Drug Quality and Security Act Implementation, 21st Century Cures Initiative, Innovation for Healthier Americans Initiative, Prescription Drug Pricing, Abuse-Deterrent Prescription Drug Formulations, H.R. 406 Combination Drug Development Incentive Act, H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act, H.R. 1576 Generic Complex Drugs Safety and Effectiveness for Patients Act
FDA Funding, H.R. 1078 FDA Safety Over Sequestration Act, S. Con. Res. 11 FY2016 Senate Budget
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2014 · fourth_quarter · Q4
Implementation of FDASIA and GDUFA, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation and Mitigation Strategies, Biosimilars Naming, Electronic Labeling for Pharmaceuticals, H.R. 5657 Fair Access for Safe and Timely Generics Act, H.R. 3116 MODDERN Cures Act, H.R. 2985 Combination Drug Development Incentive Act, H.R. 4437 Generic Drug Pricing Fairness Act, S. 3004 Dormant Therapies Act, Issues Regarding Market Exclusivity, Drug Quality and Security Act Implementation
H.R. 83 Consolidated and Further Continuing Appropriations Act
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2014 · third_quarter · Q3
H.R. 4800 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
Implementation of FDASIA and GDUFA, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation and Mitigation Strategies, Biosimilars Naming, Electronic Labeling for Pharmaceuticals, Generic Drugs Savings, H.R. 5657 Fair Access for Safe and Timely Generics Act, H.R. 3116 MODDERN Cures Act, H.R. 2985 Combination Drug Development Incentive Act, H.R. 4437 Generic Drug Pricing Fairness Act, Issues Regarding Market Exclusivity
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2014 · second_quarter · Q2
Implementation of FDASIA and GDUFA, Counterfeit Drugs/Import Safety, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar Naming, Electronic Labeling for Pharmaceuticals, H.R. 2725, FDA Safety over Sequestration Act, S. 1413, FDA User Fee Protection Act, H.R. 2985, Combination Drug Development Incentive Act, H.R. 3742, Antibiotic Development to Advance Patient Treatment Act of 2013, H.R. 486, Stop Tampering of Prescription Pills Act of 2013H.R. 4437, Generic Drug Pricing Fairness Act
H.R. 2725, FDA Safety over Sequestration Act of 2013, H.R. 4800, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, S. 2389, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, H.R.5016, Financial Services and General Government Appropriations Act, 2015, S. 1413, FDA User Fee Protection Act, FY2016 FDA Budget Request
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2014 · first_quarter · 1A
Implementation of Affordable Care Act (ACA), Medicaid Rebates, Prescription Drug Reimbursement, Medicare Part D Program and Generic Drugs, H.R. 1588 Medicare Drug Savings Act of 2013, H.R. 4160 Keep the Promise to Seniors Act, S. 740 Medicare Drug Savings Act of 2013, S. 1871 SGR Repeal and Medicare Beneficiary Access Act of 2013
FY15 Presidential Budget Request, FY15 House and Senate Financial Services Appropriations, H.R. 2725 Food and Drug Administration Safety over Sequestration Act of 2013, H.R. 2410 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014, H.J. Res. 59 Continuing Appropriations Resolution 2014, S. 1413 FDA User Fee Protection ActS. 1244 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2014 · first_quarter · Q1
Implementation of Biosimilars in the Affordable Care Act (ACA), Implementation of FDASIA and GDUFA, Counterfeit Drugs/Import Safety, Prescription Drug Importation/Re-Importation, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar Naming, Electronic Labeling for Pharmaceuticals, H.R. 486 - Stop Tampering of Prescription Pills Act of 2013, H.R. 2725 - FDA Safety over Sequestration Act, H.R. 3204 - Drug Quality and Security Act,H.R. 3709 - Protecting Consumers Access to Generic Drugs Act of 2013 S. 214 - Preserve Access to Affordable Generics Act S. 957 - Drug Supply Chain Security Act S. 1413 FDA User Fee Protection Act
Generic Drug User Fees, FDA Funding, FY15 Presidential Budget Request, FY15 House and Senate Financial Services Appropriations, H.R. 2725-Food and Drug Administration Safety over Sequestration Act of 2013, H.R. 2410-Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2014, H.J. Res. 59-Continuing Appropriations Resolution 2014, S. 1413-FDA User Fee Protection Act,S. 1244 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2014
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2013 · fourth_quarter · Q4
S. 214 - Preserve Access to Affordable Generics Act; S.504 - Fair and Immediate Release of Generic Drugs Act, H.R. 3309 Innovation Act, HR 3709 Protecting Consumers Access to Generic Drugs Act of 2013
Implementation of Health Care Reform, Medicaid Rebates, Prescription Drug Reimbursement, Medicare Part D ProgramH. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023 H.R. 1588 - Medicare Drug Savings Act of 2013 S.740 - Medicare Drug Savings Act of 2013 S. 1871 SGR Repeal and Medicare Beneficiary Access Act of 2013
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2013 · third_quarter · Q3
Generic Drug User Fees, Funding for FDA, Funding for the Office of Generic Drugs, FY14 Presidential BudgetH. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023 H.R. 2725 FDA Safety over Sequestration Act S. 1413 FDA User Fee Protection Act HR 2410 Agriculture, Rural Development, Food Drug Administration Appropriations Act 2014 S 1244 Agriculture, Rural Development, Food Drug Administration Appropriations Act 2014
FY 2014 Budget, Implementation of Health Care Reform, Medicaid Rebates, Prescription Drug Reimbursement, Medicare Part D Program and Generic DrugsH. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023 H.R. 1588 - Medicare Drug Savings Act of 2013 S.740 - Medicare Drug Savings Act of 2013
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. H.R.1314: Bipartisan Budget Act of 2015. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Inter Partes Review (IPR) process.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
FDA Funding, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2017, The Bipartisan Budget Act of 2015
Inter Partes Review (IPR) process
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Inter Partes Review (IPR) process. Patent Settlements.
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act. Generic and competition provision in the H.R.6: 21st Century Cures Act.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. Covered Outpatient Drugs (CMS-2345-FC). CMMI Part B Drug Demo.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Taxation Issues Related to Opioid Pharmaceuticals.
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
Medicare Part D Program and Generic Drugs. Medicare reimbursement for biosimilars. Medicaid Rebate Penalty. Medicare Part D Low Income Subsidy (LIS) Program. CMMI Part B Drug Demo.
Filing targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
Innovation for Healthier Americans Initiative. H.R.6: 21st Century Cures Act.
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017.
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.1314: Bipartisan Budget Act of 2015. Drug Importation. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). S.2615: Increasing Competition in Pharmaceuticals Act. Pharmaceutical exclusivity. H.R.4931: Pharmaceutical Stewardship Act of 2016. H.R.953: Comprehensive Addiction and Recovery Act of 2015 (CARA). S.3056: CREATES Act of 2016.
FDA Funding. S.2956: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.5054: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. H.R.1314: Bipartisan Budget Act of 2015. S.2837: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2017. S.3040: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.3020: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2016.
Inter Partes Review (IPR) process.
Trans-Pacific Partnership (TPP). Biologic Exclusivity.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
Inter Partes Review (IPR) process
FDA Funding, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2017, The Bipartisan Budget Act of 2015
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
H.R. 9 The Innovation Act, S. 1137 PATENT Act, S. 2019 Preserve Access to Affordable Generics Act, Inter Partes Review (IPR) process
Medicare Part D Program and Generic Drugs,H.R. 2391 Medicaid Generic Drug Price Fairness Act, S. 1364 Medicaid Generic Drug Price Fairness Act, Medicare reimbursement for biosimilars, The Bipartisan Budget Act of 2015, Fiscal Year 2016 Omnibus Appropriations Act, Covered Outpatient Drugs (CMS-2345-F)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Medicare Part D Program and Generic Drugs,H.R. 2391 Medicaid Generic Drug Price Fairness Act, S. 1364 Medicaid Generic Drug Price Fairness Act, Medicare reimbursement for biosimilars
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
H.R. 9 The Innovation Act, S. 632 STRONG Patents Act, S. 1137 Patent Act
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
Medicare Part D Program and Generic Drugs, Medicare Part D Non-Interference, Prescription Drug Pricing, Low-Income Subsidy in Part D
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R. 3709 Protecting Consumer Access to Generic Drugs Act, S. 214 Preserve Access to Affordable Generics Act, H.R. 3309 Innovation Act
Medicare Part D Program and Generic Drugs, H.R. 5748 Medicaid Generic Drug Price Fairness Act, S. 2948 Medicaid Generic Drug Price Fairness Act
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Implementation of Biosimilars in the Affordable Care Act (ACA), Implementation of FDASIA and GDUFA, Counterfeit Drugs/Import Safety, Prescription Drug Importation/Re-Importation, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar Naming, Electronic Labeling for Pharmaceuticals, H.R. 486 - Stop Tampering of Prescription Pills Act of 2013, H.R. 2725 - FDA Safety over Sequestration Act, H.R. 3204 - Drug Quality and Security Act,S. 957 - Drug Supply Chain Security Act S. 1413 FDA User Fee Protection Act
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Vice President of the U.S., White House Office
Implementation of Affordable Care Act (ACA), Medicaid Rebates, Prescription Drug Reimbursement, Medicare Part D Program and Generic Drugs, H.R. 1588 - Medicare Drug Savings Act of 2013, H.R. 4160 Keep the Promise to Seniors Act, S. 740 - Medicare Drug Savings Act of 2013, S. 1871 SGR Repeal and Medicare Beneficiary Access Act of 2013
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office
Implementation of Health Care Reform, Implementation of Generic Biologics, Counterfeit Drugs/Import Safety, Prescription Drug Importation/Re-Importation, Drug Shortages, Labeling of Generic Drugs, Risk Evaluation Mitigation Strategies, Biosimilar NamingH.R.486 - Stop Tampering of Prescription Pills Act of 2013 H.R.1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug. H.R. 1919 - Safeguarding America's Pharmaceuticals Act of 2013 H.R.1958 - Gray Market Drug Reform and Transparency Act of 2013 H.R.2186 - VALID Compounding Act of 2013 H.R. 2725 FDA Safety over Sequestration Act H.R. 3019 SAFE Compounded Drugs Act H.R. 3089 Compounding Clarity Act of 2013 H.R. 3204 Drug Quality and Security Act H.R. 3709 Protecting Consumers Access to Generic Drugs Act of 2013 H. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023 H Res - 161 Expressing the sense of the House of Representatives that the Food and Drug Administration should encourage the use of abuse-deterrent formulations of drugs S.214 - Preserve Access to Affordable Generics Act S.504 - Fair and Immediate Release of Generic Drugs Act S.621 - Safe Prescribing Act of 2013 S 957 - Drug Supply Chain Security Act S 959 - Pharmaceutical Quality, Security, and Accountability Act
Bills: H. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023; H.R. 2725 FDA Safety over Sequestration Act; H.J. Res 59 Continuing Appropriations Resolution 2014; S 1413 FDA User Fee Protection Act; HR 2410 Agriculture, Rural Development, Food Drug Administration Appropriations Act 2014;S 1244 Agriculture, Rural Development, Food Drug Administration Appropriations Act 2014 FY 2014 Budget
Filing targets: Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
FY 2014 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Prescription Drug Importation/Re-Importation, Drug Shortages, Pharmaceutical Drug Compounding, Labeling of Generic DrugsH.R.486 - Stop Tampering of Prescription Pills Act of 2013 H.R.1285 - To amend the Controlled Substances Act to make any substance containing hydrocodone a schedule II drug. H.R. 1919 - Safeguarding America's Pharmaceuticals Act of 2013 H.R.1958 - Gray Market Drug Reform and Transparency Act of 2013 H.R.2186 - VALID Compounding Act of 2013 H.R. 3019 SAFE Compounded Drugs Act H.R. 3089 Compounding Clarity Act of 2013 H.R.3204 Drug Quality and Security Act H. Con. Res. 25 - Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023 H Res - 161 Expressing the sense of the House of Representatives that the Food and Drug Administration should encourage the use of abuse-deterrent formulations of drugs S.214 - Preserve Access to Affordable Generics Act S.504 - Fair and Immediate Release of Generic Drugs Act S.621 - Safe Prescribing Act of 2013 S 957 - Drug Supply Chain Security Act S 959 - Pharmaceutical Quality, Security, and Accountability Act
S.214 - Preserve Access to Affordable Generics Act S.504 - Fair and Immediate Release of Generic Drugs Act
Filing targets: Congressional Budget Office (CBO), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE