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Precision medicine and the changing role of regulatory agencies

Nature Reviews Drug Discovery volume 15, pages 805–806 (2016)Cite this article

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Abstract

The growth of precision medicine presents challenges for the regulators of medicines, related to aspects that include the basis of evidence generation, patient involvement in the regulatory process, cost of new medicines and the need for new regulatory models. It also raises questions about the tolerance of risk, especially with early interventions for life-threatening diseases.

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Acknowledgements

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf or reflecting the position of the agencies or organizations with which the authors are affiliated.

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Authors and Affiliations

  1. Alasdair Breckenridge is at the Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool L69 3BX, UK.,

    Alasdair Breckenridge

  2. Hans-Georg Eichler is at the European Medicines Agency, London E14 5EU, UK.,

    Hans-Georg Eichler

  3. Jonathan P. Jarow is at the US Food and Drug Administration, Silver Spring, Maryland 20993, USA.,

    Jonathan P. Jarow

Authors
  1. Alasdair Breckenridge
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  2. Hans-Georg Eichler
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  3. Jonathan P. Jarow
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Correspondence to Alasdair Breckenridge.

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Breckenridge, A., Eichler, HG. & Jarow, J. Precision medicine and the changing role of regulatory agencies. Nat Rev Drug Discov 15, 805–806 (2016). https://doi.org/10.1038/nrd.2016.206

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