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Nat Rev Drug Discov 2017 Aug;16(8):513-4

Combination products: modernizing the regulatory paradigm.

Hunter NL, Sherman RE

Abstract

New opportunities to develop innovative - and often complex - products that combine drugs, devices and/or biological components are rapidly emerging, raising questions about how such products should be regulated. Here, we discuss the ongoing efforts of the FDA to develop a modern, transparent, flexible and consistent science-based regulatory approach for combination products.

Category: Journal Article, Editorial
PubMed ID: #28496147 DOI: 10.1038/nrd.2017.66
Includes FDA Authors from Scientific Area(s): Women's Health
Entry Created: 2017-05-23 Entry Last Modified: 2017-11-19
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