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 In this section:

        Guidance, Compliance & Regulatory Information (Biologics)

Biologics Procedures (SOPPs)

                        
                Section 8000: General Information
          Section 8100: Communication
          Section 8200: Investigational New Drugs (INDs)
          Section 8300: Master Files
          Section 8400: Marketing Applications
          Section 8500: Compliance
          Section 8700: Medical Devices
          Section 9150: Office of Therapeutic Products Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Procedures (SOPPs)Guidance, Compliance & Regulatory Information (Biologics) Biologics Procedures (SOPPs)
  	
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    PrintThese Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA's Center for Biologics Research and Review (CBER) in the performance of their duties.  They are made available here to the public because CBER is committed to being as transparent as possible in how it operates.  These SOPPs are organized by area of activity.

Standard Operating Policies & Procedures (SOPPs)

Section 8000: General InformationSection 8100: CommunicationSection 8200: Investigational New Drugs (INDs)Section 8300: Master FilesSection 8400: Marketing ApplicationsSection 8500: ComplianceSection 8700: Medical DevicesSection 9150: Office of Therapeutic Products

Report a Problem to the Center for Biologics Evaluation & Research
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		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
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			10903 New Hampshire Ave WO71-3103
			Silver Spring, MD 20993-0002
		
		ocod@fda.hhs.gov
		
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	Resources for You (Biologics)
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			Biologics Products & Establishments

                                                                                  Content current as of:
      02/28/2023
                  
                   
Regulated Product(s)
		 BiologicsTopic(s)
			  Application & ApprovalsBiologics Procedures (SOPPs)                
                          

                        Section 8000: General Information
          Section 8100: Communication
          Section 8200: Investigational New Drugs (INDs)
          Section 8300: Master Files
          Section 8400: Marketing Applications
          Section 8500: Compliance
          Section 8700: Medical Devices
          Section 9150: Office of Therapeutic Products
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