Drugs

Important Addresses for Regulatory Submissions

Please use the following address for these regulatory submissions

Food and Drug Administration,
Center for Drug Evaluation and Research,
Division of XXXXX,
5901-B Ammendale Road,
Beltsville, MD 20705-1266.
  • Investigational New Drug (IND) Applications
  • Therapeutic Biological Products
    • Postmarketing Adverse Experience Information
    • Advertising and Promotional Labeling
    • Biologic License Applications (BLAs)
    • BLA Supplements
    • Annual Reports on Postmarketing Studies
    • Postmarketing Study Final Reports
    • Postmarketing Study Correspondence
    • Distribution Reports

Send all reports of biologic product deviations required by 21 CFR 600.14 to:

Division of Compliance Risk Management and Surveillance (HFD-330)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane 
Rockville, MD 20857

Send biological product deviations required by 21 CFR 600.14 to sent by courier or overnight mail to:

Food and Drug Administration, CDER
Office of Compliance, Division of Compliance Risk Management and Surveillance, HFD-330
Montrose Metro 2
11919 Rockville Pike
Rockville, MD  20852

 

Page Last Updated: 12/04/2014
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