Pre-NDA Work Takes Added Importance As PDUFA V Stretches Review Cycle
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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.
To get the most out of formal interactions with the agency, sponsors must prepare thoroughly and listen for FDA “regulatory speak,” agency and industry representatives advise.
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.