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  3. Development & Approval Process (Drugs)
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Investigational New Drug (IND) Application
  7. Addresses to Send Applications
  1. Types of Applications

Addresses to Send Applications

Addresses to Send Applications

 

  • Full drug marketing application submissions under 21 CFR subpart 314.50 and 314.54 should be directed to:
Center for Drug Evaluation and Research
Food and Drug Administration
Document and Records Section
5901-B Ammendale Rd

Beltsville, Md. 20705-1266

  • Abbreviated new drug applications under 21 CFR subpart 314.94, and amendments, supplements, and resubmissions; and
  • Abbreviated antibiotic drug application submissions, as well as items sent by parcel post or overnight courier service to the Office of Generic Drugs, should be directed to:
Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North II, Room 150
7500 Standish Place
Rockville, MD 20855
  • Correspondence not associated with a particular application should be addressed specifically to the intended office or division and to the person as follows:
Center for Drug Evaluation and Research
Food and Drug Administration
Attn: [insert name of person]
HFD-[insert mail code of office or division]
5600 Fishers Lane

Rockville, MD 20857