1. United States Food and Drug Administration: The Orphan Drug Regulations. Final rule, 57 FR 62076. 21 CFR Part 316. 1992
2. Asbury CH: The Orphan Drug Act. The first 7-years. JAMA. 1991, 265: 893-7. 10.1001/jama.265.7.893.
3. National Institutes of Health: Office of Rare Diseases. 2008, (Accessed January 30, 2008)., [
http://rarediseases.info.nih.gov
]
4. United States Congress: Rare diseases act of 2002. Public Law 107–280. (Accessed January 3, 2008)., [
http://www.history.nih.gov/01docs/historical/documents/PL107-280.pdf
]
5. Office of Inspector General. United States Department of Health and Human Services: The Orphan Drug Act implementation and impact. 2001, (Accessed January 3, 2008)., [
http://oig.hhs.gov/oei/reports/oei-09-00-00380.pdf
]