1. Title 21. United States Code (USC) Section 360ee.
2. Rohde, D. D. The Orphan Drug Act: an engine of innovation, at what cost? Food Drug Law J. 55, 125–143 (2000).
3. Title 35. United States Code (USC) Sections 102–103.
4. Mathieu, M. New Drug Developments: A Regulatory Overview 4th edn (PAREXEL International, Waltham, Massachusetts, 1997).
5. Title 21. Code of Federal Regulations (CFD) Sections 314.50 and 601.40.