Science & Research
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Pediatrics
New Pediatric Labeling Information Database
Safety Reporting Updates
Pediatric Study Characteristics Database
List of Exclusivity Determinations (PDF - 179KB)
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
Scientific Activities and Statistics
Resource for information related to pediatric studies, written request for pediatric studies and literature articles
International Collaborations
Exchange of scientific and regulatory information related to pediatric therapeutics.
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