1. Orphan Drug Act, Pub. L. No 97-414, 96 Stat. 2049 (1984 as amended).
2. Available from: .
3. The tax provisions are administered by the Internal Revenue Service (see Title 26, Code of Federal Regulations, Section 45C)—Dr. Nguyen—OK?
4. See Title 21, Code of Federal Regulations, Part 316.
5. J. Mitsumoto, E.R. Dorsey, J. Thompson, R.C. Griggs, Impact of the Orphan Drug Act on Drug Development. Presented at the Conference on Clinical Research for Rare Diseases, September 5, 2007, Bethesda, MD.