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

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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 (http://www.creativecommons.org/licenses/by-nc/4.0/) Abstract A 505(b)(2)…

The Generic Challenge

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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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