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U.S. Department of Health and Human Services

Drugs

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Required Postmarketing Adverse Experience Information

Therapeutic Biological Products
Mailing Address for Required Postmarketing Adverse Experience Information

All postmarketing adverse experience information required under 21 CFR 600.80 (Postmarketing 15-day "alert Reports", Postmarketing 15-day "Alert reports"-followup, and Periodic Adverse Experience Reports) shall be sent to:

Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Road
Beltsville, MD 20705-1266