title: Prescription for the Orphan Drug Act: the impact of the FDA's 1992 regulations and the latest congressional proposals for reform.
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: D B
authors.initials: DB
authors.lastname: Clissold
mesh_terms: D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D004465:Economic Competition; D049673:History, 20th Century; D006801:Humans; D007880:Legislation, Drug / Q000266:history; D009965:Orphan Drug Production / Q000191:economics / Q000266:history / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence