Generic Drug User Fee Amendments
GPTKB entity
Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:abbreviation |
gptkb:GDUFA
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
generic drug manufacturers
|
| gptkbp:approvedBy |
2017
2022 |
| gptkbp:dateEnacted |
2012
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:goal |
improve access to safe and effective generic drugs
reduce review times for generic drug applications |
| https://www.w3.org/2000/01/rdf-schema#label |
Generic Drug User Fee Amendments
|
| gptkbp:partOf |
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
|
| gptkbp:purpose |
fund FDA review of generic drug applications
|
| gptkbp:relatedTo |
gptkb:Biosimilar_User_Fee_Act
gptkb:Prescription_Drug_User_Fee_Act |
| gptkbp:requires |
user fees from generic drug industry
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
|
| gptkbp:bfsLayer |
6
|