Late-Cycle Approval Predictions Not A Good Idea, FDA Says

OND Director John Jenkins says the late-cycle meeting in the new PDUFA review model will offer a lot of information to sponsors, but likely will not be predictive of application approvability.

Sponsors should glean a wealth of information about a pending application during the review’s late-cycle meeting in the new PDUFA V system, but they should be careful about its predictive value.

FDA will not consider it a decisional meeting, said John Jenkins, director of the Center for Drug Evaluation and Research...

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