GDUFA Reauthorization Talks Complete

September 8, 2016

The FDA and industry have finished negotiating the terms for renewing GDUFA, the agency said.

A 15-minute meeting involving five FDA officials and three industry representatives ended the negotiations and finalized the terms of the GDUFA reauthorization package on Aug. 24, according to FDA meeting minutes released Wednesday.

The draft commitment letter, which outlines the agreement reached between the two sides on reauthorizing GDUFA, has not been made public yet, but a stakeholder involved in the negotiations announced key provisions of the agreement. GDUFA expires in 2017.

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