The Center for Drug Evaluation and Research
GPTKB entity
Properties (91)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
government agency
|
| gptkbp:collaboratesWith |
academic institutions
pharmaceutical companies |
| gptkbp:conducts |
post-market surveillance
scientific reviews research on drug efficacy |
| gptkbp:develops |
regulatory science
|
| gptkbp:engagesIn |
public consultations
|
| gptkbp:ensures |
drug safety
|
| gptkbp:focusesOn |
drug approval
|
| gptkbp:has |
various divisions
|
| https://www.w3.org/2000/01/rdf-schema#label |
The Center for Drug Evaluation and Research
|
| gptkbp:isEngagedIn |
stakeholder engagement
|
| gptkbp:isInvolvedIn |
vaccine regulation
drug pricing discussions risk management programs drug safety assessments patient-reported outcomes research drug labeling regulations emergency use authorizations drug policy development biologics license applications drug safety communications drug safety research healthcare quality initiatives breakthrough therapy designations drug affordability discussions clinical pharmacology research drug policy advocacy. drug interaction studies accelerated approval pathways drug formulary decisions clinical trial design improvements clinical trial diversity initiatives drug access initiatives drug advertising compliance drug benefit design discussions drug cost-effectiveness analyses drug coverage policies drug distribution oversight drug effectiveness research drug efficacy assessments drug formulation reviews drug importation issues drug labeling compliance drug labeling updates drug manufacturing inspections drug market access strategies drug marketing regulations drug pricing transparency initiatives drug promotion oversight drug quality assessments drug research collaborations drug shortage management drug utilization studies drug value assessments fast track designations international drug regulation priority review designations real-world evidence initiatives therapeutic equivalence evaluations drug_reimbursement_policies orphan_drug_designations |
| gptkbp:isLedBy |
Director_of_CDER
|
| gptkbp:isLocatedIn |
gptkb:Silver_Spring,_Maryland
|
| gptkbp:isPartOf |
gptkb:Department_of_Health_and_Human_Services
|
| gptkbp:isResponsibleFor |
clinical trial oversight
reviewing biologics |
| gptkbp:issues |
safety alerts
drug approvals guidance documents drug recalls |
| gptkbp:isTaskedWith |
monitoring drug advertising
|
| gptkbp:monitors |
adverse drug reactions
|
| gptkbp:oversees |
generic drugs
|
| gptkbp:partOf |
gptkb:Food_and_Drug_Administration
|
| gptkbp:promotes |
patient safety
|
| gptkbp:provides |
educational resources
technical assistance regulatory updates consumer information information to healthcare professionals training for reviewers guidance for drug development |
| gptkbp:publishes |
guidelines for clinical trials
|
| gptkbp:regulates |
pharmaceuticals
|
| gptkbp:reviews |
new drug applications
|
| gptkbp:supports |
patient advocacy groups
drug innovation |
| gptkbp:wasEstablishedIn |
1962
|
| gptkbp:worksWith |
other regulatory agencies
|