Public Meeting on Generic Drug User Fee Reauthorization

FDA has announced a 10/21 public meeting to hear public comments on the recent proposed agreement to reauthorize the generic drug user fee program. The draft agreement will be finalized and delivered to Congress in January.

One major change in the draft is that review performance goals will be streamlined and consolidated so that all ANDAs and ANDA amendments would fall within a single review goals scheme to “promote review efficiency, and ensure that ‘no submission is left behind,’” the agency says. The next user fee program would also create faster review goals for priority submissions. “For an ANDA, standard review would be 10 months from submission and priority review would be eight months from submission,” it says. Additionally, there will be a new pre-ANDA program, with product development, pre-submission and mid-review-cycle meetings. And a facility will not pay an annual facility fee unless it is identified in at least one approved generic drug submission.