Important Addresses for Regulatory Submissions
Address for 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
Biologic Product Deviations Required by 21 CFR 600.14
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
Biological Product Deviations Required by 21 CFR 600.14 by Courier or Overnight Mail
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