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65992 1510824253HCLSReviewUkraineNovember2017.pdf
Energy Boardroom

30 Years of the US Generic Industry under Hatch-Waxman

04.03.2014 / Thomson Reuters Blog

In 1984 the generic industry reached a turning point. This was the year that the Drug Price Competition and Patent Term Restoration Act or “Hatch-Waxman Act” was introduced, simplifying the process for generic drug manufacturers to enter the market. Critically, the bill stipulated that generic drugs would no longer be required by the FDA to […]

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