Office of Translational Sciences

E392787

The Office of Translational Sciences is a scientific office within the U.S. Food and Drug Administration that advances the translation of biomedical research into safe and effective drug therapies through regulatory science, research, and policy development.

All labels observed (2)

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Statements (49)

Predicate Object
instanceOf FDA office ⓘ
scientific office ⓘ
activity collaborate with external scientific and academic partners ⓘ
conduct regulatory science research ⓘ
develop and apply modeling and simulation in drug development ⓘ
develop scientific policies and guidance ⓘ
evaluate clinical pharmacology aspects of drug applications ⓘ
provide quantitative and statistical support for drug review ⓘ
provide scientific training and education in regulatory science ⓘ
support biomarker development and qualification ⓘ
support clinical trial design and analysis ⓘ
country United States ⓘ
field biomedical research ⓘ
biostatistics ⓘ
clinical pharmacology ⓘ
drug development ⓘ
pharmacometrics ⓘ
regulatory science ⓘ
translational medicine ⓘ
focus benefit–risk assessment ⓘ
biomarkers and surrogate endpoints ⓘ
dose optimization ⓘ
effectiveness of human drugs ⓘ
exposure–response relationships ⓘ
innovative clinical trial methodologies ⓘ
patient-focused drug development ⓘ
quantitative methods in drug development ⓘ
safety of human drugs ⓘ
locatedIn Maryland ⓘ
Silver Spring, Maryland ⓘ
United States ⓘ
mission advance translation of biomedical research into safe and effective drug therapies ⓘ
develop and apply regulatory science tools and methods ⓘ
improve efficiency and success of drug development ⓘ
support regulatory decision-making for human drugs ⓘ
parentOrganization Center for Drug Evaluation and Research ⓘ
U.S. Food and Drug Administration ⓘ
partOf Center for Drug Evaluation and Research ⓘ
U.S. Food and Drug Administration ⓘ
regulates aspects of human nonprescription drugs ⓘ
aspects of human prescription drugs ⓘ
usesMethod advanced biostatistical methods ⓘ
clinical trial simulation ⓘ
model-informed drug development ⓘ
pharmacokinetic and pharmacodynamic analysis ⓘ
website https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-translational-sciences ⓘ
worksOn biologics license applications ⓘ
investigational new drug applications ⓘ
new drug applications ⓘ

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Referenced by (3)

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

Center for Drug Evaluation and Research → oversees → Office of Translational Sciences ⓘ
Office of Translational Sciences → website → https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-translational-sciences ⓘ
linked to: Office of Translational Sciences
Office of Biostatistics → collaboratesWith → Office of Translational Sciences ⓘ