Combination products: modernizing the regulatory paradigm

Nature Reviews. Drug Discovery
Nina L Hunter, Rachel E Sherman

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.

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Citations

Feb 7, 2018·Nature Biotechnology·Reed F Beall, Aaron S Kesselheim
Sep 17, 2019·Applied Health Economics and Health Policy·Carlos Campillo-ArteroMarta Trapero-Bertran
Jan 29, 2019·Journal of Alzheimer's Disease : JAD·Jeffrey L CummingsClive Ballard

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