title: Regulatory aspects of investigational new drugs.
abstract: Federal regulations governing the introduction of new drugs in the United States are reviewed. The discussion includes the legislative background, what constitutes a "new drug," drug development, investigational new drugs, new drug applications, pharmacist involvement in clinical trials, the approval process and postmarketing surveillance.
mesh_terms: D004341:Drug Evaluation; D049673:History, 20th Century; D007880:Legislation, Drug / Q000266:history; D010595:Pharmacists; D014481:United States; D014486:United States Food and Drug Administration