FDA Biologics (BLA & Biosimilars)Original article
Potency Assessment of Active Immunotherapy Products
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Summary
The FDA has released draft guidance on potency assessment procedures for active immunotherapy products. This represents a regulatory clarification with potential applicability to companies in the immunotherapy space.
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FDAguidanceimmunotherapypotency assessmentdraft guidance
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Published by FDA Biologics (BLA & Biosimilars) on August 19, 2026 12:59 PM