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Updated: Aug 24, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
How personalized medicine is changing the rules of drug life exclusivity
1King & Spalding LLP, 191 Peachtree St, Atlanta, GA 30303, USA. csullivan@kslaw.com
Abstract:
Personalized medicine is premised on the notion that diagnostic techniques can improve safety or effectiveness of pharmaceutical therapies based upon individual genetic or proteomic make-ups. This article explains how diagnostic techniques and pharmaceutical therapies interact during the US Food & Drug Administration's approval of branded and generic drugs in the US, and how the same labeling requirement for generic drugs of the Hatch-Waxman Act can prevent generic drugs from entering the market when proprietary pharmacogenomic techniques are incorporated into the labeling of a branded drug.
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