Anticipating REMS.
D055808:Drug Discovery / Q000592:standards*; D004358:Drug Therapy / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D012042:Registries / Q000592:standards; D012308:Risk Management / Q000458:organization & administration; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards*