GDUFA II Goal: Evaluate 90 Percent of Priority Submissions in Eight Months

October 21, 2016

The FDA intends to review 90 percent of priority review ANDAs deemed complete within eight months, according to the agency’s GDUFA II commitment letter.

The full commitment letter further explains the performance goals the FDA has committed to for the next five fiscal years after 2017, when the current agreement expires.

As in GDUFA I, the FDA plans to respond to regular ANDAs within 10 months after submission. In the past, the FDA faced a significant backlog of ANDAs that totaled more 4,700 applications. Only in the last few months has the agency reported acting on more than 90 percent of those items.

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