Craig Bleifer

Craig Bleifer

McGuireWoods LLP

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

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

1/30/2025  /  Centers for Medicare & Medicaid Services (CMS) , CMMI , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , MedPAC , New Guidance , Pharmaceutical Industry
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