Science & Research
-
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.
-
FDAAA Pediatric Tracking Requirements
- New Pediatric Labeling (PDF - 16KB)
Annual Pediatric Labeling Changes Summary (PDF - 22KB)- Pediatric Study Characteristics (PDF - 16KB)
Pediatric Formulations (PDF - 10KB)Pediatric Review Committe Priority Review Recommendations (PDF - 7KB)CBER Deferred Pediatric Studies Requested and Granted (PDF - 25KB)- CDER Deferred Pediatric Studies Requested and Granted (PDF - 78KB)
CBER Waivers of Pediatric Studies Requested and Granted (PDF - 11KB)- CDER Waivers of Pediatric Studies Requested and Granted (PDF - 9KB)
- CBER Pediatric Study Progress (PDF - 16KB)
- CDER Pediatric Study Progress (PDF - 16KB)
Annual Pediatric Postmarketing Requirements Summary (PDF - 12KB)
-
-
-