New England Journal of Medicine
November 24, 2016 Vol. 375 No. 21
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.