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
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Date created: October 9, 2003 |