Vaccines, Blood & Biologics
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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).
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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