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.
For technical questions related to GDUFA SPL submissions:
For technical questions about using the user fee collection system, the Office of Financial Management can be reached on:
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993