title: FDA and drug approval.
authors.affiliation: Pharmaceutical Safety Assessments, Inc., Narberth, PA 19072, USA.
authors.forename: G A
authors.initials: GA
authors.lastname: Faich
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003362:Cost-Benefit Analysis; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*