FDA Proposes New Drug Review Model at PDUFA Meeting With Industry

With drugmakers clamoring for more feedback from the FDA during the drug review process, the agency is considering tossing its current system and adopting a new review model. The model, which the agency proposed at a Sept. 27 Prescription Drug User Fee Act (PDUFA) reauthorization meeting with industry representatives, would seek to address drugmakers’ concerns by providing sponsors with a discipline review letter following a mid-cycle review meeting and another letter before the user fee action date. Details of the meeting were posted Tuesday on the FDA’s website.
Drug Industry Daily