title: FDA audit of nonclinical studies.
abstract: FDA is increasing its efforts to enforce regulations governing the conduct of nonclinical (animal) trials to support evidence of safety. Since the GLP regulations were promulgated in 1987, the incidence of deficiencies at these animal facilities has remained constant despite an increased number of issued warning letters. These warning letters constitute a serious breach of the FDA regulations and has resulted in certain cases in rejection of nonclinical study data, termination of the IND application, and disqualification of the facility as well as criminal prosecution of individuals involved in fraudulent practices.
authors.affiliation: Arthur M. Horowitz and Associates, Rockville, Maryland 20850-4117, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Horowitz
mesh_terms: D000827:Animal Welfare / Q000331:legislation & jurisprudence / Q000592:standards; D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000592:standards; D005161:Facility Regulation and Control / Q000266:history / Q000331:legislation & jurisprudence / Q000592:standards*; D049673:History, 20th Century; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration