Changing FDA Approval Standards: Ethical Implications for Patient Consent

Affiliations

• ¹ 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, MA, USA. jjdarrow@bwh.harvard.edu.
• ² Department of Law and Taxation, Bentley University, Waltham, MA, USA. jjdarrow@bwh.harvard.edu.
• ³ Division of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA.