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FDA (CBER)
GUIDANCE DRAFT
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry
Published: 9/24/2025Detected: 3/25/2026

Summary preview

Clarifies and proposes how FDA CBER intends to apply expedited development and review programs to regenerative medicine therapies intended for serious conditions, including more structured pathways to interact with FDA.

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manufacturing
quality
clinical
safety
labeling
rare_diseases
#CBER
#regenerative medicine therapies
#expedited programs
#serious conditions
#clinical evidence

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