One Year Later

FDASIA Marks Its First Birthday

07.09.13 | By Stephanie Fischer

It was one year ago today that the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, reauthorizing the Prescription Drug User Fee Act (PDUFA), permanently reauthorizing the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, and creating a Breakthrough Therapy designation. 

Since our last update on FDASIA and PDUFA, the FDA held the third Patient Focused Drug Development meeting, which focused on lung cancer, and scheduled the fourth meeting, which will focus on narcolepsy on September 24th. The disease areas which will be the focus of public meetings in FY2014 and FY2015 are posted on the FDA website.

FDA has also released Draft Guidance for Industry on Expedited Programs for Serious Conditions which includes a chart of the qualifying features, criteria, timelines for FDA action and other elements of the Fast Track, Breakthrough Therapy and Priority Review designations and Accelerated Approval pathway.

PhRMA and the Biotechnology Industry Organization (BIO) recently announced the creation of an Industry PDUFA Tracking Database to track member companies’ experience with the new review program for new molecular entity (NME) new drug applications (NDA) and original biologic license applications (BLA) established under PDUFA V to promote greater transparency and provide more opportunities for communication between biopharmaceutical companies and FDA.

Want to learn more about why PDUFA is important to provide timely patient access to safe and effective medicines? Check out our pocket card and watch a short video.  

FDA has a three year implementation plan for FDASIA, and charts its progress here.


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