title: IOM advises FDA on ethics in postmarket safety trials.
authors.forename: Bridget M
authors.initials: BM
authors.lastname: Kuehn
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration