Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.


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


Page Last Updated: 10/04/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English