Pediatric Drug Development: Historical References
- The Pediatric Exclusivity Provision - January 2001 Status Report to Congress (PDF - 161KB)
- Food and Drug Administration Modernization Act (FDAMA) of 1997
See section 111.
- Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric "Rule," and their Interaction
- FR: Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies (2003-2008)
- Pediatric Research Equity Act of 2003 (Public Law No: 108-155) posted 12/16/2003 (PDF - 50KB)