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date: 23 March 2018

Abstract and Keywords

This article examines the basic framework of the U.S. Food and Drug Administration (FDA)’s approval process for drugs, biologics, and medical devices within the broader context of the country’s healthcare system. The article also discusses intellectual property protections and statutory exclusivity periods for medical products and their effect on the market entry of follow-on therapies. It then considers a number of current developments shaping FDA regulation of pharmaceuticals and medical devices, including the rise of personalized medicine, the strengthening of First Amendment commercial speech protections, and the agency’s expanding involvement in the practice of medicine. Finally, the article examines how the FDA must increasingly share its gatekeeping role with third-party payers and considers the agency’s future in light of this phenomenon.

Keywords: Food and Drug Administration, drugs, biologics, medical devices, healthcare, intellectual property, exclusivity periods, market entry, medical products, regulation

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