Draft Guidance for Industry on Investigational New Drugs; Approaches to Complying with Current Good Manufacturing Practice During Phase 1; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "INDs-- Approaches to Complying with CGMP During Phase 1." This draft guidance is intended to assist persons producing drug and biological products (investigational drugs) for use during phase 1 development in complying with relevant current good manufacturing practice (CGMP) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Controls for producing an investigational new drug (IND) for use in a phase 1 study are primarily aimed at ensuring subject safety. This guidance is being issued concurrently with a direct final rule and companion proposed rule published elsewhere in this issue of the Federal Register, which, if finalized, will specify that the particular requirements in the regulations need not be met for most investigational drugs manufactured for use during phase 1 development. Instead, the agency recommends the approaches outlined in this guidance for complying with the FD&C Act.