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.
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For technical questions related to GDUFA SPL submissions:
For questions about Drug Master Files: DMFOGD@fda.hhs.gov
For technical questions about using the user fee collection system: