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  1. Guidance, Compliance & Regulatory Information (Biologics)

Biologics Post-Market Activities

FDA 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

 

Resources for You
Recalls & Alerts
Approvals & Clearances

 


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