Observational Studies of Drug Safety -- Aprotinin and the Absense of Transparency
Hiatt, William R.
New England Journal of Medicine 2006 November 23; 355(21): 2171-2173
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Guidance for Industry: Postmarketing Studies and Clinical Trials -- Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act: Drug Safety Unknown creator (United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Biologics Evaluation and Research (U.S.); and Center for Drug Evaluation and Research (U.S.), 2011)