title: Off-label drug and device applications: meeting the challenge.
authors.forename: Foad
authors.initials: F
authors.lastname: Nahai
mesh_terms: D018795:Device Approval; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000009:adverse effects; D006801:Humans; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration