Statements (49)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:appliesTo |
animal drugs
biologics biosimilars drugs food additives generic drugs medical devices over-the-counter drugs prescription drugs vaccines tobacco products diagnostic tests combination products cosmetics (in some cases) dietary supplements (in some cases) |
| gptkbp:awardedBy |
gptkb:Center_for_Biologics_Evaluation_and_Research
Center for Devices and Radiological Health Center for Drug Evaluation and Research |
| gptkbp:compatibleWith |
compounded drugs
cosmetics (in most cases) some dietary supplements |
| gptkbp:country |
gptkb:United_States
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Approval (US)
|
| gptkbp:involves |
clinical trials
preclinical studies Biologics License Application (BLA) New Drug Application (NDA) Premarket Approval (PMA) Investigational New Drug (IND) application |
| gptkbp:legalBasis |
gptkb:Public_Health_Service_Act
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act |
| gptkbp:mayBeRevoked |
if safety concerns arise
|
| gptkbp:mayInclude |
advisory committee review
|
| gptkbp:purpose |
ensure safety and efficacy of products
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:ANDA_(Abbreviated_New_Drug_Application)
gptkb:Emergency_Use_Authorization_(EUA) FDA clearance |
| gptkbp:requires |
gptkb:Risk_Evaluation_and_Mitigation_Strategies_(REMS)
post-marketing surveillance commercial distribution marketing medical products in the US |
| gptkbp:reviewedBy |
FDA reviewers
|
| gptkbp:symbolizes |
BLA number
NDA number PMA number |
| gptkbp:bfsParent |
gptkb:Digital_Radiography_System
|
| gptkbp:bfsLayer |
8
|