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  1. FDA User Fee Programs

GDUFA Reauthorization Stakeholder Meetings

GDUFA Reauthorization Stakeholder Meetings

In accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) held monthly discussions with representatives of patient and consumer advocacy groups during negotiations with the generic drug industry on reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) program. The FDA publishes all stakeholder meeting agendas and minutes on this website.

Request for Notification of Stakeholder Intention To Participate (Docket No. FDA-2012-N-0882-0026)

Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date (Docket No. FDA-2012-N-0882-0004) 

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