Office of Surveillance and Epidemiology

E392786

The Office of Surveillance and Epidemiology is a U.S. FDA office responsible for monitoring the safety and effectiveness of marketed drugs and therapeutic biologics through post-market surveillance and risk assessment.

All labels observed (1)

Label Occurrences
Office of Surveillance and Epidemiology canonical 2

How this entity was disambiguated

Statements (41)

Predicate Object
instanceOf FDA office ⓘ
pharmacovigilance organization ⓘ
abbreviation OSE ⓘ
collaboratesWith Office of New Drugs ⓘ
other FDA centers ⓘ
country United States ⓘ
field drug safety ⓘ
epidemiology ⓘ
pharmacovigilance ⓘ
risk management ⓘ
goal to identify and assess postmarketing safety risks ⓘ
to monitor effectiveness of marketed drugs ⓘ
to monitor safety of marketed drugs ⓘ
governmentBranch executive branch of the United States federal government ⓘ
jurisdiction United States Food and Drug Administration ⓘ
language English ⓘ
locatedIn Silver Spring, Maryland ⓘ
United States ⓘ
parentAgency Center for Drug Evaluation and Research ⓘ
partOf Center for Drug Evaluation and Research ⓘ
U.S. Food and Drug Administration ⓘ
regulates marketed over-the-counter drugs ⓘ
marketed prescription drugs ⓘ
therapeutic biologic products ⓘ
responsibleFor benefit-risk assessment of approved products ⓘ
evaluation of adverse drug events ⓘ
post-market safety surveillance of drugs ⓘ
post-market safety surveillance of therapeutic biologics ⓘ
postmarketing requirements and commitments review support ⓘ
risk assessment of marketed drugs ⓘ
risk assessment of therapeutic biologics ⓘ
risk evaluation and mitigation strategies support ⓘ
signal detection for drug safety issues ⓘ
sector public health ⓘ
regulatory science ⓘ
supervisesProcess postmarketing pharmacovigilance ⓘ
risk management planning for drugs ⓘ
usesDataSource FDA Adverse Event Reporting System ⓘ
usesMethod database analyses ⓘ
observational epidemiologic studies ⓘ
website https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-surveillance-and-epidemiology ⓘ

How these facts were elicited

Referenced by (2)

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

Center for Drug Evaluation and Research → oversees → Office of Surveillance and Epidemiology ⓘ
Office of Biostatistics → collaboratesWith → Office of Surveillance and Epidemiology ⓘ