FDA releases draft guidance on potency testing for immunotherapy products
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The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs).
The guidance covers products such as cancer vaccines and therapies for autoimmune conditions, outlining recommended approaches for measuring biological activity and ensuring consistency.
By clarifying expectations, the agency hopes to streamline development and regulatory review of these emerging treatments, providing sponsors with a clearer framework for assay design and validation.
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This writeup was produced by pharmadog from original reporting by raps.
Original headline: “FDA drafts guidance on assessing potency of immunotherapy products”
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