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- FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapiesThe FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…
- FDA releases draft guidance on container closure and device components for biosimilar combination productsThe FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products. The guidance f…