Center for Drug Evaluation and Research

E85252

U.S. Food and Drug Administration center drug regulatory authority component regulatory agency division

The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.

Aliases (4)

Statements (49)

Predicate	Object
instanceOf	U.S. Food and Drug Administration center → drug regulatory authority component → regulatory agency division →
abbreviation	Center for Drug Evaluation and Research → surface form: "CDER"
collaboratesWith	Center for Biologics Evaluation and Research → Center for Devices and Radiological Health →
country	United States of America →
field	clinical research → drug regulation → pharmacology → public health →
goal	protect public health by ensuring safe and effective drugs → provide clear and science-based drug information to the public →
headquartersLocation	Silver Spring, Maryland NERFINISHED → White Oak Federal Research Center →
jurisdiction	United States government → surface form: "federal government of the United States"
language	English →
locatedInTimeZone	Eastern Time Zone →
oversees	Office of Biostatistics → Office of Compliance → Center for Drug Evaluation and Research → surface form: "Office of Generic Drugs" Center for Drug Evaluation and Research → surface form: "Office of New Drugs" Office of Pharmaceutical Quality → Office of Surveillance and Epidemiology → Office of Translational Sciences →
parentOrganization	Food and Drug Administration → surface form: "U.S. Food and Drug Administration"
partOf	United States Department of Health and Human Services → surface form: "U.S. Department of Health and Human Services"
regulates	biologic drug products shared with CBER → drug advertising review → drug labeling → drug manufacturing quality → generic drugs → over-the-counter drugs → prescription drugs → therapeutic biologics assigned to CDER →
responsibleFor	abbreviated new drug application review → clinical pharmacology and biopharmaceutics review → drug safety communications → ensuring effectiveness of human drugs in the United States → ensuring quality of human drugs in the United States → ensuring safety of human drugs in the United States → good manufacturing practice oversight for drugs → guidance documents for industry on drug development → new drug application review → over-the-counter drug monograph system → postmarketing drug safety surveillance → risk evaluation and mitigation strategies oversight →
uses	benefit-risk assessment for drug approvals →
website	Center for Drug Evaluation and Research → surface form: "https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder"

Referenced by (5)

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

Center for Drug Evaluation and Research → abbreviation → Center for Drug Evaluation and Research →

this entity surface form: "CDER"

Food and Drug Administration → hasDivision → Center for Drug Evaluation and Research →

Center for Drug Evaluation and Research → oversees → Center for Drug Evaluation and Research →

this entity surface form: "Office of New Drugs"

Center for Drug Evaluation and Research → oversees → Center for Drug Evaluation and Research →

this entity surface form: "Office of Generic Drugs"

Center for Drug Evaluation and Research → website → Center for Drug Evaluation and Research →

this entity surface form: "https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder"