Biologics Rules

Proposed & Final Rules specifically related to biologics are organized by biologics product area.  Cross-Center and Office of the Commissioner Proposed and Final Rules are posted in a general FDA Rules section.

Should you find a link that does not work that's embedded within Guidance documents, Rules, and other documents posted on the FDA Web site, please try searching for the document using the document title. For more assistance, go to Contact FDA.

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Biologics Notices, Proposed and Final Rules

• General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
• Blood Notices, Proposed and Final Orders, Proposed and Final Rules
• Tissue Notices, Proposed and Final Rules
• Vaccine Notices, Proposed and Final Rules

General

• FDA Rules and Regulations

Related Links

• Code of Federal Regulations (CFR)
• Federal Register (FR)
• Federal eRulemaking Portal

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The latest information from the Center for Biologics Evaluation and Research.