Tag: rare disease

  • FDA Orphan Drug Designation (ODD)

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    History and Background In 1983, US Congress passed the Orphan Drug Act as an amendment to the federal Food Drug and Cosmetic Act (FDC Act) to advance the development of drugs that demonstrate promise to diagnose or treat rare diseases or conditions. In 1993, FDA issued regulations in 21 CFR 316 detailing the implementation of…