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Precision medicine and the FDA's draft guidance on laboratory-developed tests

Nature Biotechnology volume 33, pages 449451 (2015) | Download Citation

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Author information

Affiliations

  1. Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts, USA.

    • Thomas J Hwang
  2. The Blackstone Group, London, United Kingdom.

    • Thomas J Hwang
  3. Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

    • Lisa Soleymani Lehmann
  4. Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

    • Aaron S Kesselheim

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Competing interests

T.J.H. is employed by Blackstone, but Blackstone and Blackstone's clients were not involved in the decision to pursue this research project and did not contribute in any way to it. The views expressed in this manuscript are those of the authors and do not represent the views of, and do not constitute a recommendation by, Blackstone or any of its affiliated or subsidiary entities. The authors' employers, grantors and funders had no role in the design and conduct of the study; preparation, review or approval of the manuscript; or the decision to submit the manuscript for publication.

Corresponding author

Correspondence to Aaron S Kesselheim.

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DOI

https://doi.org/10.1038/nbt.3221

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