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                International Activities

International Activities

                        Regulatory Harmonization and Convergence
          Foreign Regulators – Information and Training Resources
          Foreign Regulator Information Exchanges
          International Engagements to Respond to Covid-19 Pandemic
          Quick Guide to Web Resources
          Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics


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          International Activities
          Quick Guide to Web ResourcesInternational Activities Quick Guide to Web Resources
  
  	
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    PrintCBER Product Approvals/Clearances and Establishments

CBER's Licensed Products and Establishments
	Allergenics
	CBER Device Pre-Market Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) [devices associated with blood donor testing]
	Vaccines
	More CBER Product Approvals/Clearances and EstablishmentsCompliance Actions (Biologics)

Enforcement Actions (CBER)
	Warning Letters
	Untitled Letters (CBER)
	Biological Product Deviations
	Biological Product Deviation Reports Annual Summaries
	Transfusion/Donation Fatalities
	Enforcement Reports
	Suspension Letters, Notice of Intent to Revoke, and HCT/P Orders
	More Compliance Actions (Biologics)Safety and Availability (CBER Biologics)

Vaccine Adverse Events
	Recalls (Biologics)
	Counterfeit Medicine
	More Safety and Availability (CBER Biologics)Development and Approval Process (CBER)

Investigational New Drug Applications (INDs) for CBER-Regulated Products
	Biologics License Applications (BLA) Process (CBER)
	Premarket Notification 510(k) Process for CBER-Regulated Products
	Premarket Approval (PMA) for CBER-Regulated Products
	New Drug Application (NDA) Process (CBER)
	Regulatory Submissions in Electronic Format for CBER-Regulated Products
	More Development and Approval Process (CBER)Guidance, Compliance and Regulatory Information (Biologics)

Guidance, Compliance & Regulatory Information (Biologics)

                                                                                  Content current as of:
      03/04/2020
              
              
Regulated Product(s)
		 BiologicsInternational Activities

          
                        Regulatory Harmonization and Convergence
          Foreign Regulators – Information and Training Resources
          Foreign Regulator Information Exchanges
          International Engagements to Respond to Covid-19 Pandemic
          Quick Guide to Web Resources
          Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics


                        WHO Engagements
 
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