- New Pediatric Labeling Information Database
- Safety Reporting Updates - Pediatric Advisory Committee Recommendations and Subsequent Outcomes
- Pediatric Study Characteristics Database
- List of Exclusivity Determinations (PDF - 179KB)
- Medical, Statistical, and Pharmacology Reviews 7/9/2012- present
- Medical, Statistical and Pharmacology Reviews 9/2007- 7/2012
- Medical, Statistical and Pharmacology Review Summaries 1/2002-9/2007
- PREA Automatic Waivers List
Persons with disabilities having problems accessing the above PDF files may call 301-796-8653 for assistance.
Resource for pediatric safety information related to drugs, biologics and devices
Resource to assure that all FDA-regulated clinical trials enrolling children are scientifically sound and ethically appropriate
Resource for information related to pediatric studies, written request for pediatric studies and literature articles
Exchange of scientific and regulatory information related to pediatric therapeutics.