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. 2017 Aug;16(8):513-514.
doi: 10.1038/nrd.2017.66. Epub 2017 May 12.

Combination products: modernizing the regulatory paradigm

Nina L Hunter  1 , Rachel E Sherman  1
Affiliations

Combination products: modernizing the regulatory paradigm

Nina L Hunter et al. Nat Rev Drug Discov. 2017 Aug.

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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References

    1. Science. 2015 Nov 27;350(6264):1084-9 - PubMed

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