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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  3. Guidance, Compliance & Regulatory Information (Biologics)
  4. Biologics Post-Market Activities
  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


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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

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