Investigational New Drug Applications; Proposed Amendment to Clinical Hold Regulations for Products Intended for Life- Threatening Diseases
Federal Register 1997 September 24; 62(185): 49946-49954
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Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions Unknown creator (United States. Food and Drug Administration [FDA]. Center for Drug Evaluation and Research [CDER], 2002-03)