PDUFA Reauthorization Goals and Meeting

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA released its performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) reauthorization for FY 2018-2022 and held a public meeting on August 15 to draw in further public comment. The written comment period extended to August 22. The current PDUFA (V) legislation extends to September 2017. FDA will revise its recommendations as necessary based on the industry input and present its proposed recommendations to the Congressional committees for the reauthorization program (PDUFA VI). PDUFA’s intent is to “provide additional revenues so that FDA can hire more staff, improve systems, and established a better-managed human drug review process to make important therapies available to patients sooner without compromising review quality or FDA’s high standards for safety, efficacy, and quality.” The 50 page 2018-2022 performance goal document provides insight into the current review issues, including CMC, and how they can be further addressed.
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