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Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements


This article was originally published by Ingrid Freije, Stéphane Lamouche, and Mario Tanguay in Ther Innov Regul Sci. 2019 Jan 7:2168479018811889 under a Creative Commons Attribution-NonCommercial 4.0 License ( Abstract A 505(b)(2)…

The Generic Challenge


The generic pharmaceutical industry exists at the intersection of business, science, law, and government regulation. To be perform well in any of these disparate areas requires deep specialization (e.g. a…

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