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        Guidance, Compliance & Regulatory Information (Biologics)

Biologics Post-Market Activities

                        
                CBER’s Sentinel Program
          Postmarketing Clinical Trials


                Lot Release Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Post-Market ActivitiesGuidance, Compliance & Regulatory Information (Biologics) Biologics Post-Market Activities
  	
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    PrintFDA continues to assure product safety and efficacy even after a product is approved.  These post-market activities include lot release (for some products), post-marketing adverse event reporting, and post-marketing study commitments (also known as Phase IV studies).

Post-Market Activities

CBER’s Sentinel Program
	CBER-Regulated Products: Shortages and Discontinuations
	Lot Release
	Postmarketing Clinical Trials
	Recalls (Biologics)Sub-Topic Paragraphs
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                                                                                  Content current as of:
      01/25/2021
                  
                   
Regulated Product(s)
		 BiologicsBiologics Post-Market Activities                
                          

                        CBER’s Sentinel Program
          Postmarketing Clinical Trials


                        Lot Release
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