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 MoreCan the FDA Rely on Political Issues for Product Approval?
In the current environment, there may be concern that the FDA would act under improper political influence rather than in accordance with its scientific expertise.
View Full ArticleThe 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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