title: Hints on preparing successful orphan drug designation requests.
authors.affiliation: Porton International Inc., Washington, D.C., USA.
authors.forename: P V
authors.initials: PV
authors.lastname: Buday
mesh_terms: D017277:Drug Approval; D006801:Humans; D007880:Legislation, Drug; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration