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Generic Drugs Priorities & Projects

Generic Drugs Priorities & Projects

In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives on generic drugs. These priorities are discussed and developed in public meetings and workshops, resulting in several awarded projects each year.

Research Priorities

Public Workshops

Regulatory Science Public Meetings and Workshops

Awarded Projects

GDUFA Implementation

  • Bi-Annual Industry Regulatory Science Work Group Meeting – February 25, 2019
  • Bi-Annual Industry Regulatory Science Work Group Meeting – November 1, 2018
  • Bi-Annual Industry Regulatory Science Work Group Meeting – April 10, 2018