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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
Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.
Back to The New Drug Development Process
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