Tag: CFR

  • 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…

  • FDA Expanded Access Programs

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    History and Background Expanded Access Programs (EAP) are governed by 21 CFR 312, Subpart I and are also referred to as “compassionate use.” They are designed to allow use of investigational drugs outside a clinical trial for subjects who do not meet the requirements of active running trial(s). There are 3 types of EAP: individual…