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.
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.