GDUFA II Expected to Speed Approvals, Increase Transparency

October 28, 2016

The FDA hopes to create a faster review period for approving generics in the next iteration of GDUFA.

Those priority review submissions would be evaluated in 8 months from the initial ANDA submission date, the FDA said.  ANDAs that could fall under this review category include first generics and copycat products that address drug shortages.

The FDA intends to review ANDAs within a single scheme eliminating yearly cohorts “to simplify and consolidate program administration” and “ensure that ‘no submission is left behind.’”  In GDUFA I, the agency evaluated submissions in cohorts and set action dates based on those cohorts.

For the next version of GDUFA, the standard review of an ANDA will take 10 months from its original submission date instead of the current 10 to 15 months.

The consolidated review program would inform applicants within 60 days from submission whether the agency will accept the ANDA for evaluation.

FDA project managers will be available to provide generics makers with status updates on ANDAs as well.  They will offer sponsors projected dates for FDA action and notify them of any major deficiencies in submissions.

Complex generic products, such as drug-device products, will have a pre-submission program that builds “an enhanced pathway” for approval, the FDA said. The program will include product development, pre-submission and mid-review meetings to give generics makers targeted scientific advice.

The FDA will host a public meeting to receive stakeholder feedback on the performance goals.

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