title: FDA urged to reduce REMS program burdens.
authors.forename: Kate
authors.initials: K
authors.lastname: Traynor
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D018570:Risk Assessment / Q000331:legislation & jurisprudence*; D012308:Risk Management / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration