Articles

The Generic Drug User Fee Act - A Brief Overview

The Generic Drug User Fee Act (GDUFA) was signed into law as part of the 2012 Food and Drug Administration Safety and Innovation Act. It sets in motion the administrative steps needed to better fund the Agency's review of generic drug products—a process in which an abbreviated new drug application (ANDA) review now takes almost three years. The goal is to bring this review time down to less than a year. However, it is definitely a work in progress.


Breakthrough Therapies - A New FDA Paradigm

The flexibility promised in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) continues to be rolled out at the Agency. FDASIA includes a provision that allows sponsors to request that their drug be designated as a "Breakthrough Therapy". FDA is in the process of developing guidance related to this designation, but Sponsors can now submit requests for Breakthrough Therapy designation. Presumably, breakthrough therapies will cover such agents as those which appear to provide unmet medical needs for important healthcare conditions.