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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Speeding Therapy Access Today Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
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
2023 · first_quarter · Q1
Prescription Drug Costs. Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. Labeling of Generic Drugs and Biosimilars. Section 505(j)(10) Labeling [Legislation not yet introduced]. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. Incentivize Domestic Manufacturing. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. FDA Inspections. Energy & Commerce Factory Inspection Legislation. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. Shaheen-Cassidy Citizen Petition Legislation. 506I Marketing Status Updates. Buy American Proposals. Issues Related to COVID-19. Inflation Reduction Act (IRA) Implementation.
Source: Senate LDA
FDA Modernization Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
FDA Modernization Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
FDA Modernization Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
FDA Modernization Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Consolidated Appropriations Act, 2023
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Prompt Approval of Safe Generic Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Prompt Approval of Safe Generic Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Prompt Approval of Safe Generic Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Prompt Approval of Safe Generic Drugs Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Protecting Access to Affordable Medicines Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Protecting Access to Affordable Medicines Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Protecting Access to Affordable Medicines Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Protecting Access to Affordable Medicines Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Essential Medicines Strategic Stockpile Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Essential Medicines Strategic Stockpile Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R. 4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927: MADE in America Act.
Stop Stalling Access to Affordable Medications
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Veterans Health Care Freedom Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
ENACT Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
ENACT Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
ENACT Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
ENACT Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
MADE in America Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R. 4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927: MADE in America Act.
MADE in America Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. Mexico Patent Linkage. H.R.4521/S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
MADE in America Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. US-India Trade Discussions. US-UK Intellectual Property Policies. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
BENEFIT Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
FACTS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
United States Innovation and Competition Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. US-India Trade Discussions. US-UK Intellectual Property Policies. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
United States Innovation and Competition Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. Mexico Patent Linkage. H.R.4521/S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
United States Innovation and Competition Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R. 4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927: MADE in America Act.
International Pharmaceutical Supply Chain Security Agreement Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. Mexico Patent Linkage. H.R.4521/S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
International Pharmaceutical Supply Chain Security Agreement Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R. 4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927: MADE in America Act.
International Pharmaceutical Supply Chain Security Agreement Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. US-India Trade Discussions. US-UK Intellectual Property Policies. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
DIVERSE Trials Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
DIVERSE Trials Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
DIVERSE Trials Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
DIVERSE Trials Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Reduced Costs and Continued Cures Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Reduced Costs and Continued Cures Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Reduced Costs and Continued Cures Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Reduced Costs and Continued Cures Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Inflation Reduction Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Inflation Reduction Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Inflation Reduction Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
FORWARD Act of 2021
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
ARPA–H Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Cures 2.0 Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Cures 2.0 Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Cures 2.0 Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Cures 2.0 Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
CREATE Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
CREATE Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
CREATE Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Data Transparency and Drug Safety Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Data Transparency and Drug Safety Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Data Transparency and Drug Safety Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Data Transparency and Drug Safety Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Improved Transparency of Foreign Drug Manufacturing Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Improved Transparency of Foreign Drug Manufacturing Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Improved Transparency of Foreign Drug Manufacturing Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Improved Transparency of Foreign Drug Manufacturing Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Inflation Prevention Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Inflation Prevention Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Patients’ Right to Know Their Medication Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
DEPICT Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
DEPICT Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
DEPICT Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
DEPICT Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Helping Experts Accelerate Rare Treatments Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Accelerated Approval Integrity Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Accelerated Approval Integrity Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Accelerated Approval Integrity Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Accelerated Approval Integrity Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Give Kids a Chance Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Enhanced Access to Affordable Medicines Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Enhanced Access to Affordable Medicines Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Enhanced Access to Affordable Medicines Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Enhanced Access to Affordable Medicines Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
To direct the Secretary of Health and Human Services to conduct a pilot program under which the Secretary increases the conduct of unannounced inspections of foreign human drug establishments and evaluates the differences between inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Drug Manufacturing Innovation Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Drug Manufacturing Innovation Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Drug Manufacturing Innovation Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Drug Manufacturing Innovation Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Accelerating Access for Patients Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Accelerating Access for Patients Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
Accelerating Access for Patients Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Accelerating Access for Patients Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
INSPECTIONS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
INSPECTIONS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
INSPECTIONS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
INSPECTIONS Act
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Pre-approval Information Exchange Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
Pre-approval Information Exchange Act of 2022
Client: ASSOCIATION FOR ACCESSIBLE MEDICINES · Firm: ASSOCIATION FOR ACCESSIBLE MEDICINES
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain Challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. U.S.-India Trade Discussions.
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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2022 · fourth_quarter · Q4
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain Challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. S.3799: PREVENT Pandemics Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2022 · third_quarter · Q3
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. Mexico Patent Linkage. H.R.4521/S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Emergency Management Agency (FEMA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2022 · second_quarter · Q2
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Shipping Delays. US-India Trade Discussions. US-UK Intellectual Property Policies. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927/S.2082: MADE in America Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2022 · first_quarter · Q1
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.
General Trade Issues. Drug Supply Chain. Sterile Injectable Supply Chain challenges. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R. 4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Shipping Delays. US-India Trade Discussions. China Patent Listing. S.3799: PREVENT Pandemics Act. H.R.4521: America COMPETES Act of 2022. S.1260: United States Innovation and Competition Act of 2021. H.R.3927: MADE in America Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Emergency Management Agency (FEMA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
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2021 · fourth_quarter · Q4
General Trade Issues. Drug Supply Chain. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. US-India Trade Discussions. TRIPS Waivers. Enhanced Access to Affordable Medicines Act. Shipping Delays.
Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. H.R.2565: FDA Modernization Act of 2021 as it relates to alternative testing methods to animal testing to investigate the safety and effectiveness of a drug, and for other purposes. FDA Inspections. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. H.R.2910: Veterans Health Care Freedom Act. H.R.5376: Build Back Better Act.
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2021 · third_quarter · Q3
General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. US-India Trade Discussions. TRIPS Waivers.
Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. H.R.5388/S.2740: PREPARE Act. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Biosimilars Misinformation. FDA Inspections. FDA and Future Public Health Emergencies. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications.
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2021 · second_quarter · Q2
Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. FDA Inspections. FDA and Future Public Health Emergencies. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021.
General Trade Issues. Drug Supply Chain. S.1176: Onshoring Essential Antibiotics Act. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. H.R.2653/S.1203: Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2021. S.1366: Pharmaceutical Supply Chain Defense and Enhancement Act. S.1367: United States Pharmaceutical Supply Chain Review Act. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-India Trade Discussions. TRIPS Waivers.
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2021 · first_quarter · Q1
General Trade Issues. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. United States-Mexico-Canada (USMCA) Implementation. US-UK Trade Agreement. US-India Trade Discussions. US-European Trade Discussions. US-China Trade Discussions. TRIPS Waivers.
Prescription Drug Costs. Drug Pricing. Pharmaceutical Exclusivity. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Orange Book. Drug Shortages. S.917: Short on Competition Act. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Buy American Proposals. Issues Related to COVID-19. Secretary Azar Importation Plan.
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2020 · fourth_quarter · Q4
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. Pharmaceutical Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. Carter Supply Chain Legislation. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-China Trade Discussions.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilar Insulin. Labeling of Generic Drugs and Biosimilars. S.1681: Advancing Education on Biosimilars Act of 2020. Labeling Carve-Outs. GSK v. Teva. H.R.5668: MODERN Labeling Act of 2020. S.1636: Ensuring Innovation Act. Drug Shortages. Stockpile of Generic Drugs. H.R.7507: State Stockpile Readiness Act of 2020. H.R.8479: Essential Medicines Strategic Stockpile Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. S.844: Short on Competition Act. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. H.R.8529: Protecting Access to Affordable Medicines Act of 2020. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.1895: Lower Health Care Costs Act. Pharmaceutical Exclusivity. H.R.8905: Supply Chain Security and Pharmaceutical Authentication Act of 2020. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.1503: Orange Book Transparency Act of 2020. H.R.1520: Purple Book Continuity Act of 2020. Issues Related to COVID-19. Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Buy American Proposals. Buy American Executive Order.
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2020 · third_quarter · Q3
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. Consent to FDA Approval. Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. S.4492: Safe Drugs Act. Country of Manufacture Labeling. Modern Labeling. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. Stockpile of Generic Drugs. H.R.6516: Stockpiling for America's Future Endeavors Act of 2020. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. Executive Order 13947/13948: Lowering Drug Prices by Putting America First. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Orange Book. Issues Related to COVID-19. Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Rubio Coronavirus Plan. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
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2020 · second_quarter · Q2
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. H.R.6393/S.3538: Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). FDA Inspections. FDA Enforcement Discretion. Consent to FDA Approval. Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. Continuous Manufacturing. Approval of Supplements to ANDA Changing Manufacturing Locations. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. Reciprocal Marketing Authorization. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Purple Book Modernization. Orange Book. Issues Related to COVID-19. Implementation of H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. Implementation of H.R.6201: Families First Coronavirus Response Act. Implementation of S.3630: Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. Buy American Executive Order. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
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2020 · first_quarter · Q1
General Trade Issues. Biologic Exclusivity. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. H.R.6049/S.3343: Medical Supply Chain Security Act. S. ___Strengthening Americas Supply Chain and National Security Act. S. ___More Accurate Supply Chain Information. H.R.___LOSS Act. Air Transport of Pharmaceuticals. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. U.S.-China Phase 1 Trade Deal. Secretary Azar Importation Plan.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. S.3537: A bill to require the Secretary of Health and Human Services to maintain a list of the country of origin of all drugs marketed in the United States, to ban the use of Federal funds for the purchase of drugs manufactured in China, and for other purposes. S.3538: A bill to require the Secretary of Defense to submit to Congress a report on the reliance by the Department of Defense on imports of certain pharmaceutical products made in part or in whole in certain countries, to establish postmarket reporting requirements for pharmaceuticals, and for other purposes. FDA Priority MAPP 5240.3 REV 5. H.R.5668: MODERN Labeling Act of 2020. Drug Shortages. S.2723: Mitigating Emergency Drug Shortages Act. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. H.R.4244: MAGIC Act. Pass Through Payments for Biosimilars. Cost Sharing for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. H.R.5982: Safe Medicine Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. 180-Day Exclusivity. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. S.3384: Lowering Prescription Drug Prices for Americas Seniors and Families Act of 2020. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2214: NO BAN Act. H.R.4793: Budgeting for Opioid Addiction Treatment Act. Issues Related to COVID-19. H.R.748/S.3548: Coronavirus Aid, Relief, and Economic Security (CARES) Act. H.R.6201: Families First Coronavirus Response Act. S. ___Facilitating Innovation to Fight Coronavirus Act. Rubio Coronavirus Plan. Commission on Americas Medical Security Act. Buy American Proposals. S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.
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2019 · fourth_quarter · Q4
General Trade Issues. Trans-Pacific Partnership (TPP). Biologic Exclusivity. Pharmaceutical Exclusivity. United States-Mexico-Canada Agreement (USMCA). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. U.S.-India Trade Discussions. U.S.-European Trade Negotiations. U.S.-China Trade Negotiations. Secretary Azar Importation Plan.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. H.R.5381: International Pharmaceutical Transparency Act of 2019. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. Drug Pricing. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. FDA Citizen Petitions. H.R.2387: STOP GAMES Act of 2019. H.R.1506: FAIR Generics Act. H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. S.475: RxCAP Act of 2019. 180-Day Exclusivity. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. S.3092: Expanding Access to Low-Cost Generics Act of 2019. S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.3: Lower Drug Costs Now Act of 2019. S.1895: Lower Health Care Costs Act. S.1805: Better Tools for Healthy Living Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA).
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2019 · third_quarter · Q3
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs and Biosimilars. Country of Manufacture Labeling. Drug Compounding. Drug Shortages. Product Hopping. H.R.4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. S.1140: Protecting Access to Biosimilars Act of 2019. H.R.4455: BIOSIM Act. H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019. H.R.4629: Star Rating for Biosimilars Act. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Proposed Anti-Kickback Statute (AKS) Rebates. FDA Citizen Petitions. Suitability Petitions. S.660: Efficiency and Transparency in Petitions Act. H.R.2387: STOP GAMES Act of 2019. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.2455/S.1169: Ensuring Timely Access to Generics Act of 2019. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. Drug Pricing. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. H.R.2374/S.1224: Stop STALLING Act. H.R.2376: Prescription Pricing for the People Act of 2019. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S.378: Stop Price Gouging Act. H.R.3: Lower Drug Costs Now Act of 2019. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. 30-Month Stays. Orphan Drug Exclusivity. Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2019 · second_quarter · Q2
General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act. United States-Mexico-Canada Agreement (USMCA). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. U.S.-Japan Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Negotiations. China Tariffs.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Drug Shortages. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Proposed Anti-Kickback Statute (AKS) Rebates. FDA Citizen Petitions. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. S.61: Safe and Affordable Drugs from Canada Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. S.1416: Affordable Prescriptions for Patients Act of 2019. S.1224: Stop STALLING Act. H.R.447/S.97: Affordable and Safe Prescription Drug Importation Act. S.124: Freedom to Compete Act. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S. 378: Stop Price Gouging Act. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act of 2019. S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. S.1895: Lower Health Care Costs Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. Biologic Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.
ASSOCIATION FOR ACCESSIBLE MEDICINES via ASSOCIATION FOR ACCESSIBLE MEDICINES
2019 · first_quarter · Q1
General Trade Issues. Trans-Pacific Partnership (TPP). Transatlantic Trade and Investment Partnership (TTIP). Biologic Exclusivity. United States-Mexico-Canada Agreement (USMCA). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. China Tariffs.
Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Drug Shortages. Biosimilars Naming. Biosimilars Insulin. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.985: FAST Generics Act of 2019. H.R.1506: FAIR Generics Act. H.R.1503: Orange Book Transparency Act of 2019. H.R.1520: Purple Book Continuity Act of 2019. S.61: Safe and Affordable Drugs from Canada Act of 2019. S.64: Preserve Access to Affordable Generics and Biosimilars Act. H.R.447/S.97: Affordable and Safe Prescription Drug Importation Act. S.124: Freedom to Compete Act. H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019. H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019. H.R.465/S.102: Prescription Drug Price Relief Act of 2019. H.R.1093/S. 378: Stop Price Gouging Act. S.474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019. S.475: Reducing Existing Costs Associated with Pharmaceuticals for Seniors (RxCAP) Act of 2019. S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. S.440: Preserving Access to Cost Effective Drugs (PACED) Act. H.R.965/S.340: CREATES Act of 2019. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Pharmaceutical Exclusivity. Biologic Exclusivity. S.659: Biologic Patent Transparency Act. Biologics Price Competition and Innovation Act (BPCIA). Public Law 115-52: FDA Reauthorization Act of 2017.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
General Trade Issues. Pharmaceutical Exclusivity. Quality Supply Chain. Drug Supply Chain. Pharmaceutical Supply Chain. AAM Blueprint to Enhance the Security of the U.S. Supply Chain. Carter Supply Chain Legislation. S.4175: Pharmaceutical Supply Chain Defense and Enhancement Act. United States-Mexico-Canada Agreement (USMCA). U.S.-UK Trade Agreement. U.S.-Kenya Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Discussions. U.S.-China Trade Discussions. Secretary Azar Importation Plan.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office
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), Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE, U.S. Trade Representative (USTR)
General Trade Issues. Trans-Pacific Partnership (TPP). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.3379: Price Relief, Innovation, and Competition for Essential Drugs Act. United States-Mexico-Canada Agreement (USMCA). North American Free Trade Agreement (NAFTA). U.S.-UK Trade Agreement. U.S.-Japan Trade Discussions. U.S.-India Trade Discussions. U.S.-European Trade Negotiations. China Tariffs. Secretary Azar Importation Plan.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
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 Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)