Our mission is to help FDA-regulated organizations accurately assess their FDA regulatory risks and opportunities - and to enable them to take decisive action to achieve their scientific and commercial goals.

The Generic Drug User Fee Act - A Brief Overview

The Generic Drug User Fee Act sets in motion the administrative steps needed to better fund the Agency's review of generic drug products.  The goal is to bring this review time down to less than a year.

Breakthrough Therapies – A New FDA Paradigm

The FDA Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request their drug be designated as a "Breakthrough Therapy". Sponsors can now submit requests for Breakthrough Therapy designation.