Pediatric Tracking Requirements Under FDAAA

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant to FDAAA.

In accordance with section 505A (Best Pharmaceuticals for Children Act of 2007 (BPCA)) and section 505B (Pediatric Research Equity Act of 2007 (PREA)) of the Federal Food, Drug, and Cosmetic Act, as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), this website provides information resulting from pediatric studies conducted in response to a Written Request issued under BPCA and pediatric assessments conducted under PREA. Unless otherwise noted, these reports contain information from both CDER and CBER.

FDAAA Pediatric Tracking Requirements

• Pediatric Labeling Changes
• Annual Pediatric Labeling Changes Summary (PDF)
• Pediatric Study Characteristics
• Pediatric Formulations (PDF)
• Pediatric Review Committee Priority Review Recommendations (PDF)
• CBER Deferred Pediatric Report (PDF)
• CDER Deferred Pediatric Studies Requested and Granted (PDF)
• CBER Waivers (PDF)
• CDER Waivers of Pediatric Studies Requested and Granted (PDF)
• CBER Pediatric Study Progress Report (PDF)
• CDER Pediatric Study Progress (PDF)
• Annual Pediatric Postmarketing Requirements Summary (PDF)
• FDAAA Assessments (PDF)
• CDER Deferred Pediatric Studies Granted Table (XLS)
• CDER Waivers of Pediatric Studies Granted Table (XLS)