FDA Draft Guidance on Potency Assessment of Active Immunotherapy Products
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YouTubeU.S. Food and Drug Administration
FDA Draft Guidance on Potency Assessment of Active Immunotherapy Products
On August 20, 2026, FDA published a draft guidance with recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). This recorded webinar provides a high-level overview of the draft guidance document featuring Ramjay Vatsan, PhD from FDA’s Office of Therapeutic ...
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