FDA (CBER)
GUIDANCE FINAL
Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products
Published: 11/2/2026Detected: 11/2/2026
Summary preview
Establishes FDA expectations for potency assurance across the lifecycle of cellular and gene therapy products, with an emphasis on linking product characterization to manufacturing controls.
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quality
clinical
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#cellular therapy
#gene therapy
#potency assay
#critical quality attributes
#CMC
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