-
Drugs
-
Resources for You
-
-
Pediatric Drug Development
Many of FDA's initiatives around pediatrics have aimed to improve medical product research in children. This is making for safer and more effective treatments.
-
Notice of Pediatric Formulations Not Marketed
- Formulations Not Marketed (PDF - 18KB)
Posted 3/11/2010
-
-
FDA Amendments Act of 2007 (FDAAA)
- FDAAA - Title IV: Pediatric Research Equity Act of 2007 (PREA) and Title V: Best (PDF - 383KB)
- PREA Retrospective Review (PDF - 281KB)
- Internal Review Committee - Memorandum Establishing Pediatric Review Committee (PDF - 257KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
- New Pediatric Information in Labeling - Searchable (PDF - 1149KB)
New Pediatric Information in Labeling - FDAAA Pediatric Studies Characteristics
- Breakdown of FDAAA Completed Pediatric Studies
-
-
Best Pharmaceuticals for Children Act (BPCA and Pediatric Exclusivity)
- The Pediatric Exclusivity Provision - January 2001 Status Report to Congress (PDF - 161KB)
- Full Text of FDAMA law
FDA Modernization Act - see Section 111 - Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A o (PDF - 57KB)
- Best Pharmaceuticals for Children Act, January 4, 2002 (Public Law No. 107-109) (PDF - 76KB)
-
-
FDAMA and Best Pharmaceuticals for Children Act of 2002
-
-
BPCA/Off-Patent Drugs
-
-
BPCA/Access to New Therapeutic Agents for Pediatric Cancer
-
-
Pediatric Research Equity Act (PREA)
-
-
FDA Pediatric Ethics Working Group Consensus Statement on Pediatric Advisory Subcommittee Meetings
-
-
Historical References
-
-
-