title: Orphanage at the FDA.
authors.affiliation: Humanitarian Use Devices Designation Program, Office of Orphan Products Development, Food and Drug Administration, Silver Spring, MD, USA. eric.chen@fda.hhs.gov
authors.forename: Eric
authors.initials: E
authors.lastname: Chen
mesh_terms: D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D055808:Drug Discovery / Q000191:economics / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence; D061214:Patient Safety; D035583:Rare Diseases / Q000188:drug therapy* / Q000191:economics; D012109:Research Support as Topic; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000191:economics / Q000331:legislation & jurisprudence