Statements (64)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
legislation
|
| gptkbp:addresses |
advertising of pharmaceuticals
|
| gptkbp:amends |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:encourages |
post-market surveillance
innovation in drug development collaboration in research patient enrollment in trials data sharing in research transparency in drug approval |
| gptkbp:enhances |
FDA's_regulatory_framework
|
| gptkbp:established |
Drug Efficacy Study Implementation
Drug_Approval_Advisory_Committees New_Drug_Application_process |
| gptkbp:facilitates |
drug recalls
|
| https://www.w3.org/2000/01/rdf-schema#label |
McClellan-Kirkpatrick Act
|
| gptkbp:impact |
public health policy
clinical trial design medical device regulations drug pricing policies drug approval timelines drug marketing practices drug distribution practices FDA_authority |
| gptkbp:influences |
pharmaceutical regulations
clinical research standards healthcare_legislation |
| gptkbp:involves |
regulatory compliance
pharmaceutical companies stakeholder engagement healthcare_professionals clinical trial participants |
| gptkbp:leads |
better patient outcomes
improved healthcare outcomes enhanced drug monitoring improved drug efficacy increased accountability in drug approval increased drug research |
| gptkbp:mandates |
safety monitoring
safety assessments risk-benefit analysis safety labeling changes |
| gptkbp:promotes |
patient safety
healthcare quality evidence-based medicine drug safety |
| gptkbp:purpose |
to improve the safety and efficacy of drugs
|
| gptkbp:relatedTo |
drug approval process
|
| gptkbp:requires |
adverse event reporting
post-marketing studies safety data collection clinical trials for drug approval ethics review for trials informed consent for trials labeling of drugs |
| gptkbp:signature |
President_John_F._Kennedy
|
| gptkbp:supports |
consumer protection
patient advocacy public awareness campaigns public health initiatives research funding scientific integrity healthcare_research |
| gptkbp:yearEstablished |
1966
|