Precision medicine and the FDA's draft guidance on laboratory-developed tests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