Cures Act Changes Regarding the Regulation of Combination Products (Section 3038); Importing Hatch-Waxman Into Medical Device Approval/Clearance

JEFFREY K. SHAPIRO | December 9, 2016

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We’ve previously posted some summaries of the 21st Century Cures Act (Cures Act), which the President signed into law on December 13, 2016 (Public Law No. 114-255). (Those summaries are available here, here, and here.) This post focuses on only one section of the new law: Cures Act Section 3038, titled “Combination Product Innovation.” We did not cover Section 3038 in great detail in our prior summaries. Instead, given the significant changes made to the law and the potentially wide-ranging effects, we knew that a stand-alone post would be necessary.

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Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people.

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