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Combination products: modernizing the regulatory paradigm

Nature Reviews Drug Discovery volume 16, pages 513–514 (2017)Cite this article

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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. Drues, M. Combination products 101: a primer for medical device makers. Med Device Online https://www.meddeviceonline.com/doc/combination-products-a-primer-for-medical-device-makers-0001 25 Mar (2014).

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Acknowledgements

The authors would like to thank S.Lard, T. Nguyen and J. Weiner (at the FDA) for their valuable assistance in facilitating the development of the paper and N. Derr (at the FDA) for her editorial assistance.

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Authors and Affiliations

  1. Office of Medical Products and Tobacco, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, 20993, Maryland, USA

    Nina L. Hunter & Rachel E. Sherman

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  1. Nina L. Hunter
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  2. Rachel E. Sherman
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Corresponding author

Correspondence to Nina L. Hunter.

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The authors declare no competing financial interests.

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FURTHER INFORMATION

21 USC 353(g). Federal Food, Drug, and Cosmetic Act. Section 503(g). Regulation of combination products

US Food and Drug Administration. Advancing regulatory science

H.R.6 - 21st Century Cures Act

MACI

Kidney Health Initiative

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Hunter, N., Sherman, R. Combination products: modernizing the regulatory paradigm. Nat Rev Drug Discov 16, 513–514 (2017). https://doi.org/10.1038/nrd.2017.66

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