FDA (CBER)
GUIDANCE FINAL
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products: Guidance for Industry
Published: 8/19/2026Detected: 9/4/2026
Summary preview
Clarifies FDA CBER’s expectations for developing potential cellular and gene therapy products, emphasizing coordinated planning across manufacturing (CMC), clinical development, and safety follow-up.
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#cellular therapy
#gene therapy
#CMC
#quality attributes
#risk management
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