FDA Regulatory Review, Guidance and Strategy

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

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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.

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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".

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