PDUFA V Reviews Are ‘Best Ever’ For Some Sponsors, Maybe Not FDA
FDA officials suggest allowing late-cycle meeting opt-out and question the impact of the new lengthened review system in interim assessment of the ‘Program.’
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Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.