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
- CBER’s Sentinel Program
- CBER-Regulated Products: Shortages and Discontinuations
- Lot Release
- Postmarketing Clinical Trials
- Recalls (Biologics)
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Food and Drug Administration
Food and Drug Administration
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10903 New Hampshire Ave
Silver Spring, MD 20993
United States
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The latest information from the Center for Biologics Evaluation and Research.