Pediatrics
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- 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 (Archive)
- PREA Automatic Waivers List
Persons with disabilities having problems accessing the above PDF files may call 301-796-8653 for assistance.
Safety
Resource for pediatric safety information related to drugs, biologics and devices
Pediatric Ethics
Resource to assure that all FDA-regulated clinical trials enrolling children are scientifically sound and ethically appropriate
Pediatric Science and Research Activities
Resource for information related to pediatric studies, written request for pediatric studies and literature articles
Pediatric Cluster
Exchange of scientific and regulatory information related to pediatric therapeutics.
Pediatric Statistics
Advisory Committee Meetings
- Pediatric Advisory Committee
- Web-Posted Pediatric Safety Reviews
- Pediatric Advisory Committee Meeting Materials, 1999 - 2014
Parents and Children
- Medicines in My Home (MIMH)
- Children's Health
- Should Your Child Be in a Clinical Trial?
- Pediatric Medical Countermeasures for Disasters
Spotlight
- Common Commentary for submission of iPSPs and PIPs for COVID-19 (PDF- 271KB)
- 2019 Meeting Materials, Pediatric Advisory Committee
- Status Report to Congress: Best Pharmaceuticals for Children Act and Pediatric Research Equity Act
- Advancing the Development of Pediatric Therapeutics 5 (ADEPT5): Advancing Pediatric Pharmacovigilance Public Workshop, September 14, 2018
About Us
Related FDA Links
- FDA Pediatric Safety Communications
- Pediatric Product Development
- Developing Products for Rare Diseases & Conditions
- Pediatric Medical Devices
External Links
- AAP FDA Update Publications
- Gaucher Disease - A Strategic Collaborative Approach From EMA and FDA
- Teaching Kids About Using Medicine Safely
- Childhood Obesity (CDC)
- NIH/NICHD/Formulation
- WHO List of Essential Medicines for Children
- Children's Oncology Group
- Glaser Pediatric Research Network
- European Medicines Agency (Paediatric medicine)
- Get Email Updates