"Single Patient Use" and "Emergency Use" Situations in Drug Review by the Food and Drug Administration
HUMAN GENE THERAPY 1993 April; 4(2): 201
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Recommendations for Implementation of Community Consultation and Public Disclosure Under the Food and Drug Administration's "Exception From Informed Consent Requirements for Emergency Research": A Special Report From the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: Endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine Halperin, Henry; Paradis, Norman; Mosesso, Vincent Jr.; Nichol, Graham; Sayre, Michael; Ornato, Joseph P.; Gerardi, Michael; Nadkarni, Vinay M.; Berg, Robert; Becker, Lance; Siegler, Mark; Collins, Megan; Cairns, Charles B.; Biros, Michelle H.; Vanden Hoek, Terry; Peberdy, Mary Ann (2007-10-16)
Emergency Medicine and the Development of the Food and Drug Administration's Final Rule on Informed Consent and Waiver of Informed Consent in Emergency Research Circumstances Biros, Michelle H.; Runge, Jeffrey W.; Lewis, Roger J.; Doherty, Christopher (1998-04)This article reviews the federal regulations for emergency and acute resuscitation research in effect prior to October 1996, the historical issues that contributed to the development of these regulations, the controversies that ...