title: Standards of clinical investigations in the USA.
abstract: The drug approval process in the USA is under constant surveillance, monitoring and evaluation. Several significant changes were made during the past few years and many others are under consideration. The FDA has undergone organizational changes, which together with the IND Rewrite and NDA Rewrite resulted in a shift of emphasis in clinical studies.
authors.affiliation: University of Cincinnati Medical Center, OH.
authors.forename: W A
authors.initials: WA
authors.lastname: Ritschel
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval; D004335:Drug and Narcotic Control; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration