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Inflation Reduction Act (IRA) Food and Drug Administration (FDA) CMMI

McGuireWoods LLP

Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies

McGuireWoods LLP on

The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval Program, including a focus on product withdrawal and requirements for ongoing confirmatory...more

Akin Gump Strauss Hauer & Feld LLP

Drug Pricing Déjà Vu: The Biden-Harris Administration’s Fiscal Year 2024 Budget Doubles Down on Inflation Reduction Act Reforms;...

Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...more

Foley Hoag LLP

HHS Issues Report Outlining Three New Drug Models for Testing by CMMI

Foley Hoag LLP on

On February 14, 2023, and in response to Executive Order 14087 (“Lowering Prescription Drug Costs for Americans”), the Secretary of Health and Human Services (HHS) issued a report announcing the selection of three models that...more

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