Advisory Committee Will Cause FDA To Miss PDUFA Date For Auxilium’s Xiaflex
This article was originally published in The Pink Sheet Daily
Delay may be sign of FDAAA-produced drag on approvals; firm says no new data needed.
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FDA advisory committee participants with personal financial conflicts of interest may fully participate in committee meetings, according to the agency's new conflict of interest policy. The final guidance eliminates the draft provision that financial conflicts of any sort preclude an opportunity for panelists to vote
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.