NME Sponsors Followed PDUFA V’s “Program” To Advisory Committee Success In 2013
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.
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Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.
Merck’s anesthesia reversal agent, which was deemed “not approvable” in 2008, faces another setback as FDA cancels its July 18 advisory committee meeting to allow more time to review clinical trial site inspection data.
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.