Pediatric Drug Development: Historical References
- Pediatric Cancer Therapeutics: Letter of Interest (2/11/2000)
The Pediatric Exclusivity Provision - January 2001 Status Report to Congress(PDF - 161KB) Food and Drug Administration Modernization Act (FDAMA) of 1997
See section 111.
Best Pharmaceuticals for Children Act, January 4, 2002 (Public Law No. 107-109)(PDF - 76KB)
- Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric "Rule," and their Interaction
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability