Lexology January 29, 2025
- 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 trials.
- Accelerated Approval continues to be controversial, with benefits and drawbacks being debated by stakeholders.
- The intersection between the FDA’s Accelerated Approval Program and drug pricing issues, including proposals on Accelerated Approval drugs by the Medicare Payment Advisory Commission (MedPAC), the Centers for Medicare and Medicaid Services’ (CMS’s) drug pricing models under the Center for Medicare and Medicaid Innovation (CMMI) and CMS’s implementation of the Inflation Reduction Act (IRA), is still developing.
- The incoming Trump administration’s position on Accelerated Approval and related drug pricing issues has yet to...
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