title: The regulation of investigational drugs.
authors.affiliation: Jack D. Weiler Hospital of the Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY 10461.
authors.forename: D A
authors.initials: DA
authors.lastname: Kessler
mesh_terms: D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans; D011367:Professional Staff Committees; D014481:United States; D014486:United States Food and Drug Administration