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

E886017

FDA office government organization pediatric regulatory office

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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All labels observed (1)

Label	Occurrences
U.S. Food and Drug Administration Office of Pediatric Therapeutics canonical	1

Statements (49)

Predicate	Object
instanceOf	FDA office ⓘ government organization ⓘ pediatric regulatory office ⓘ
collaboratesWith	FDA Center for Biologics Evaluation and Research NERFINISHED ⓘ FDA Center for Devices and Radiological Health NERFINISHED ⓘ FDA Center for Drug Evaluation and Research NERFINISHED ⓘ other federal pediatric research programs ⓘ
country	United States of America ⓘ surface form: 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 government ⓘ surface form: United States federal government
locatedIn	Maryland ⓘ Silver Spring, Maryland NERFINISHED ⓘ United States of America ⓘ surface form: United States
parentOrganization	U.S. Food and Drug Administration NERFINISHED ⓘ
partOf	U.S. Food and Drug Administration NERFINISHED ⓘ
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 ⓘ

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

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