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

Follow CBER

Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

ocod@fda.hhs.gov

(800) 835-4709
(240) 402-8010

For Updates on Twitter, follow @fdacber

• Resources for You (Biologics)
• About the Center for Biologics Evaluation and Research (CBER)
• Report a Problem to the Center for Biologics Evaluation & Research
• Recalls (Biologics)
• CBER-Regulated Products: Shortages and Discontinuations
• Biologics Products & Establishments