Statements (73)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
advisory committee
|
| gptkbp:advises |
on labeling issues
|
| gptkbp:are |
temporary or permanent
important for public health subject to federal regulations a critical component of drug development process a forum for scientific debate a key part of the regulatory framework a mechanism for expert consultation a mechanism for stakeholder feedback a platform for interdisciplinary collaboration a platform for stakeholder engagement a source of expert opinion a source of transparency comprised of diverse members critical for drug approval process essential for informed decision-making often convened for controversial products often involved in vaccine approvals a_resource_for_the_FDA's_scientific_community a_vital_part_of_the_FDA's_advisory_process established_by_the_FDA integral_to_the_FDA's_mission |
| gptkbp:can_be |
address health disparities
hold public meetings evaluate emerging technologies address ethical issues advise on food safety issues advise on post-market surveillance assess the impact of new regulations assess the implications of new findings assess the need for additional research assess the validity of scientific evidence evaluate the effectiveness of interventions provide insights on market access recommend additional studies review applications for new drugs review clinical study protocols review post-market studies review product labeling review risk management plans |
| gptkbp:canBe |
advise on combination products
advise on ethical considerations in research advise on international standards advise on public health emergencies advise on regulatory science advise on the development of guidelines. advise on the use of biomarkers include patient representatives influence public perception provide input on clinical guidelines provide recommendations on clinical trial design provide recommendations on device approvals provide recommendations on labeling changes provide recommendations on risk communication provide recommendations on safety monitoring |
| gptkbp:composedOf |
experts in various fields
|
| gptkbp:evaluates |
safety and efficacy
risk-benefit analysis new therapies |
| gptkbp:focusesOn |
medical products
|
| gptkbp:function |
provide expert advice
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA advisory committees
|
| gptkbp:includes |
scientific panels
|
| gptkbp:influence |
FDA_decisions
|
| gptkbp:meets |
regularly
|
| gptkbp:partOf |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:provides |
public input
guidance on clinical practices |
| gptkbp:recommendation |
regulatory actions
|
| gptkbp:reportsTo |
findings_to_the_FDA
|
| gptkbp:reviews |
clinical trial data
adverse event reports |