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FDA Guidance for Industry: Collecting and Providing 702(b) Portions of FDA Official Samples



This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) and its implementing regulation in Title 21 Code of Federal Regulations (CFR) section 2.10 (21 CFR 2.10).

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