An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Generic Drug User Fee Amendments

GDUFA II Stakeholder Meeting Materials (FDA Archive)

GDUFA Reauthorization Stakeholder Meetings

Top

August 31, 2016 Stakeholder Meeting Materials

July 28, 2016 Stakeholder Meeting Materials

June 30, 2016, Stakeholder Meeting Materials

May 17, 2016, Stakeholder Meeting Materials

April 12, 2016, Stakeholder Meeting Materials

March 23, 2016, Stakeholder Meeting Materials

February 24, 2016, Stakeholder Meeting Materials

January 27, 2016, Stakeholder Meeting Materials