|
|
|
LifeScienceHistory.com - Check us out on Instagram
Take Your Next Career Step with Lundback
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
|
|
|
|