Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links

Drugs

-

Pediatric Drug Development: Historical References

-

Historical References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

-

-

-