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 Center for Drug Evaluation and Research
surface form: Office of New Drugs

other FDA centers
country United States of America
surface form: 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 Food and Drug Administration
surface form: United States Food and Drug Administration
language English
locatedIn Silver Spring, Maryland
United States of America
surface form: United States
parentAgency Center for Drug Evaluation and Research
partOf Center for Drug Evaluation and Research
Food and Drug Administration
surface form: 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