title: Experimental use and the Orphan Drug Act: a biotechnology conundrum.
authors.affiliation: Holme Roberts & Owen, Boulder, CO 80302, USA. hrob@netone.com
authors.forename: P J
authors.initials: PJ
authors.lastname: Koivuniemi
mesh_terms: D001709:Biotechnology; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D015195:Drug Design; D004345:Drug Industry / Q000331:legislation & jurisprudence; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence*; D010330:Patents as Topic; D014481:United States; D014486:United States Food and Drug Administration