U.S. Food and Drug Administration Office of Pediatric Therapeutics

E886017

The U.S. Food and Drug Administration Office of Pediatric Therapeutics is an FDA office dedicated to ensuring that medical products are appropriately studied, labeled, and regulated for safe and effective use in children.

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Statements (49)

Predicate Object
instanceOf FDA office ⓘ
government organization ⓘ
pediatric regulatory office ⓘ
collaboratesWith FDA Center for Biologics Evaluation and Research ⓘ
FDA Center for Devices and Radiological Health ⓘ
FDA Center for Drug Evaluation and Research ⓘ
other federal pediatric research programs ⓘ
country United States ⓘ
field biologics regulation ⓘ
drug regulation ⓘ
medical device regulation ⓘ
pediatric clinical research ⓘ
pediatric safety ⓘ
pediatrics ⓘ
pharmacology ⓘ
regulatory science ⓘ
focusesOn children ⓘ
children and adolescents ⓘ
infants ⓘ
neonates ⓘ
hasMission coordinate pediatric activities across FDA centers ⓘ
ensure that medical products used in children are safe and effective ⓘ
improve labeling of medical products for pediatric use ⓘ
promote appropriate study of medical products in pediatric populations ⓘ
jurisdiction United States federal government ⓘ
locatedIn Maryland ⓘ
Silver Spring, Maryland ⓘ
United States ⓘ
parentOrganization U.S. Food and Drug Administration ⓘ
partOf U.S. Food and Drug Administration ⓘ
regulates pediatric use of biological products ⓘ
pediatric use of human drugs ⓘ
pediatric use of medical devices ⓘ
regulatoryScope biologic therapies for pediatric use ⓘ
medical devices intended for children ⓘ
over-the-counter drugs for pediatric use ⓘ
prescription drugs for pediatric use ⓘ
responsibleFor advising on pediatric clinical trial design ⓘ
coordinating pediatric advisory committee activities ⓘ
implementing pediatric provisions of FDA legislation ⓘ
reviewing pediatric safety information for medical products ⓘ
topic long-term safety of drugs in children ⓘ
pediatric clinical trial ethics ⓘ
pediatric dosing and pharmacokinetics ⓘ
pediatric extrapolation of efficacy data ⓘ
pediatric rare diseases ⓘ
worksOn pediatric labeling changes ⓘ
pediatric research ethics issues ⓘ
pediatric safety monitoring ⓘ

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White Oak, Maryland → isNearFederalFacility → U.S. Food and Drug Administration Office of Pediatric Therapeutics ⓘ