title: Will FDA relinquish the "gold standard" for new drug approval? Redefining "substantial evidence" in the FDA Modernization Act of 1997.
authors.forename: J
authors.initials: J
authors.lastname: Kulynych
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000592:standards; D019317:Evidence-Based Medicine; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000639:trends