Maximizing PDUFA V Meeting Opportunities Requires Work By Sponsors
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.
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FDA’s Anti-Infective Drugs Advisory Committee endorsed Vibativ for limited use in nosocomial pneumonia. The committee was convened at the recommendation of Office of New Drugs Director John Jenkins, who denied the company’s appeal of a second “complete response” letter but urged the NDA be re-evaluated.
Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.