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    • The FDA and Gene Therapy for Duchenne Muscular Dystrophy

      Journal of the American Medical Association· 1 day ago

      The US Food and Drug Administration (FDA) grants accelerated approval that includes the standard of a surrogate outcome that is “reasonably likely” to predict clinical benefit ...

    • FDA Brings Lab Tests Under Its Oversight

      FDA Brings Lab Tests Under Its Oversight

      MedPage Today· 3 days ago

      The FDA issued its final rule to regulate laboratory-developed tests (LDTs), the agency said Monday. LDTs are in vitro diagnostic products (IVDs)...