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.

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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 of America
surface form: 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 of America
surface form: 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
Food and Drug Administration
surface form: U.S. Food and Drug Administration
partOf Center for Drug Evaluation and Research
Food and Drug Administration
surface form: 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 Office of Translational Sciences self-linksurface differs
surface form: 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)

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Center for Drug Evaluation and Research oversees Office of Translational Sciences
Office of Translational Sciences website Office of Translational Sciences self-linksurface differs
this entity surface form: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-translational-sciences
Office of Biostatistics collaboratesWith Office of Translational Sciences