New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
Federal Register 2002 May 31; 67(105): 37988-37998
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Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies Are Not Feasible; Determination Under the Interim Rule That Informed Consent Is Not Feasible for Military Exigencies; Request For Comments Unknown author (United States. Food and Drug Administration, 1997-07)