title: FDA attempting to overcome major roadblocks in monitoring drug safety.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: Zielinski
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence / Q000592:standards; D026661:Clinical Trials Data Monitoring Committees; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug / Q000639:trends; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration