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U.S. Department of Health and Human Services

For Industry

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Contact GDUFA

New materials will be posted on www.fda.gov/gdufa as soon as they are available.  Individuals may sign up on the GDUFA webpage to receive email updates.  If you have not already done so, please sign up for notification

Phone:
866-405-5367
301-796-6707

Email:
AskGDUFA@fda.hhs.gov

Address:
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

For technical questions related to GDUFA SPL submissions:
CDEReFacility@fda.hhs.gov

For questions about Drug Master Files: OGDDMF@fda.hhs.gov

For technical questions about using the user fee collection system:
Phone:
301-796-7200 

Email:
userfees@fda.gov 

 

CDER Small Business and Industry Assistance

(866)-405-5367 (301)-796-6707