FDA Releases Interim Report on Program To Enhance Drug Review Transparency

The Food and Drug Administration March 31 released an interim report for fiscal 2013-2014 that assesses its program to enhance drug review transparency and communication.

The program is part of commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), which allows the FDA to collect user fees for the review of drug and biologics applications for fiscal 2013-2017, the report said. In PDUFA V, the FDA instituted a new review model for new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs) that promotes enhanced communication between the FDA and applicants ...