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.
NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.