GDUFA II to Review 90 Percent of Priority Submissions in 8 Months

The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter.

The full commitment letter, which was released late Friday, 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.

The FDA is, however, saying that it will aim to notify generics makers of its decision to receive or refuse an ANDA within 60 days of submission. Previously, under GDUFA I, the FDA had not made provisions for this.

The timeframe for the FDA to act on prior approval supplements remains the same as in the GDUFA I. In the GDUFA II letter, the FDA commits to responding to standard PASs that do not require a preapproval inspection within six months after submission. For those with preapproval inspections, the FDA pledges to act within 10 months of the submission date.

Additionally, the letter commits the FDA to responding to product development meeting requests within 30 days of the request for FY 2018 and 2019. For the last three years of the user fee goals, the FDA intends to quicken turnaround and respond within 90 days of receipt of the request. These would be entirely new provisions in GDUFA that were not addressed in the first user fee agreement.

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