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.
Learn MoreThe 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.
View Full ArticleBreakthrough 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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