Precision medicine and the FDA's draft guidance on laboratory-developed tests

Affiliations

¹ 1] Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts, USA. [2] The Blackstone Group, London, United Kingdom.
² Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
³ 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.

Thomas J Hwang et al. Nat Biotechnol. 2015 May.

. 2015 May;33(5):449-51.

doi: 10.1038/nbt.3221.

¹ 1] Faculty of Arts and Sciences, Harvard University, Cambridge, Massachusetts, USA. [2] The Blackstone Group, London, United Kingdom.
² Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
³ 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.

No abstract available

References