Lexology October 6, 2025
Holland & Knight LLP

Highlights

  • The U.S. Food and Drug Administration (FDA) issued new draft guidance on Sept. 20, 2025, surrounding expedited programs for regenerative medicine therapies for serious conditions.
  • The draft guidance details FDA’s expedited review pathways to facilitate development and streamlined review of cell and gene therapies and other regenerative medicine products.
  • Once finalized, this draft guidance will supersede earlier FDA guidance on the topic.

The U.S. Food and Drug Administration (FDA) on Sept. 20, 2025, issued draft guidance, “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions,” outlining how sponsors can utilize FDA’s expedited review pathways to facilitate development and streamlined review of cell and gene therapies and other regenerative medicine products. Once finalized, the draft guidance will supersede...

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Topics: FDA, Govt Agencies
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