Learning From Its Successes? FDA Wants Feedback On All First-Cycle Actions For Assessment Program
This article was originally published in The Pink Sheet Daily
Interviews with all sponsors that receive a first-cycle action, approvals as well as other outcomes, under PDUFA V’s new NME and original BLA review program will help FDA assess the program’s success.
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New review model’s elements, including the mid-cycle communication and late-cycle meeting, helped make for a smoother advisory committee process for Janssen’s Olysio and Bayer’s Adempas. The sponsors and FDA review staff were able to reach agreement on labeling and other review issues in advance, narrowing the scope of matters requiring vetting by the expert panels.
FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.
Twenty sponsors now have applications in the new review model, but none have reached the approval decision stage; industry officials say it still is too early to draw conclusions.