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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Important Addresses for Regulatory Submissions
  1. Types of Applications

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

Resources

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