Biologics Guidances

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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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Biologics

• Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024

• Withdrawn Guidances (Biologics)

• Class II Special Controls Documents

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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