New England Journal of Medicine
January 15, 2015 Vol. 372 No. 3
Sharing Individual Patient Data from Clinical Trials
Jeffrey M. Drazen, M.D.
N Engl J Med 2015; 372:201-202January 15, 2015DOI: 10.1056/NEJMp1415160
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Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs
J.J. Darrow, A. Sarpatwari, J. Avorn, and A.S. Kesselheim
The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.