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- FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten genericsThe Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
- FDA releases draft guidance on potency testing for immunotherapy productsThe FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs).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…