Pediatrics Drug Development: Historical References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)
• Retrospective Review of Information Submitted & Actions Taken in Response to PREA 2003 (as required by FDAAA)