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Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. Guidance documents are not regulations and alternative approaches may be chosen to comply with laws and regulations.
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Recently Issued Guidance Documents
Biologics
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Summary Document Issue Date FDA Organization regulated product taxonomy hidden Topic old hidden Topic Guidance Status Open for Comment Comment Closing Date on Draft Docket Number Guidance Type hidden center taxonomy hidden
