Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Industry

  • Print
  • Share
  • E-mail
-

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

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

For technical questions about using the user fee collection system, the Office of Financial Management can be reached on:
Phone:
301-796-7200 

Email:
userfees@fda.gov

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

 

-
-