On August 13, 2009, FDA issued 21 CFR Part 312 and 316 Charging for Investigational Drugs Under an Investigational New Drug Application; Expanded Access to Investigational Drugs for Treatment Use; Final Rules. These rules address clinical studies conducted under an IND as well as treatment protocols and treatment INDs. Part 312 discusses regular INDs while Part 316 discusses the regulations surrounding orphan drug applications.

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