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        Guidance, Compliance & Regulatory Information (Biologics)

Biologics Rules

                        
                Blood Notices, Proposed and Final Orders, Proposed and Final Rules
          General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
          Tissue Notices, Proposed and Final Rules
          Vaccine Notices, Proposed and Final Rules Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics RulesGuidance, Compliance & Regulatory Information (Biologics) Biologics Rules
  	
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    PrintProposed & 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.

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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 RulesGeneral

FDA Rules and RegulationsRelated Links

Code of Federal Regulations (CFR)
	Federal Register (FR)
	Federal eRulemaking PortalSub-Topic Paragraphs
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		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

                                                                                  Content current as of:
      07/07/2022
                  
                   
Regulated Product(s)
		 BiologicsBiologics Rules                
                          

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