Biochemical Assays, Cell Based Assays and Regulations

Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” morphological cell changes or alterations in protein production or expression).

Production

Production FDA Therapies Biochemical Assays

Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Stay Connected