Fifty Years of Expert Advice — Pharmaceutical Regulation and the Legacy of the Drug Efficacy Study

New England Journal of Medicine
November 24, 2016 Vol. 375 No. 21
http://www.nejm.org/toc/nejm/medical-journal

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Perspective
History of Medicine
Fifty Years of Expert Advice — Pharmaceutical Regulation and the Legacy of the Drug Efficacy Study
Jason L. Schwartz, Ph.D., M.B.E.
N Engl J Med 2016; 375:2015-2017 November 24, 2016 DOI: 10.1056/NEJMp1609763
The role of panels of experts from outside government in the FDA’s day-to-day work derives from the Drug Efficacy Study of the 1960s, which addressed many concerns that continue to shape discussions of pharmaceutical regulation.