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- FDA releases draft guidance on potency testing for immunotherapy productsThe FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
- FDA rejects ITM radiopharma therapy while WHO defends immunization schedulesThe U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…