FDA presents draft agreement on GDUFA reauthorization

The US Food and Drug Administration and representatives from the generic drug industry have reached an agreement in principle on proposed recommendations for the first reauthorization of the generic drug user fee program.

The FDA published the draft agreement for public comment and will hold a public meeting on October 21, 2016 to hear additional public comments. The final recommendations are scheduled to be delivered to Congress in January 2017.

As part of the second iteration of the Generic Drug User Fee Amendments (GDUFA), the draft commitment letter incorporates several lessons learned over the last five years, the agency stated. Industry stakeholders support the provisions in the draft commitment letter.