FDA GUIDANCE · FINALMay 5, 2026

Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status

Final

Topic

Chemistry, Manufacturing, and Controls (CMC), Gene Therapy

Issue date

May 5, 2026

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