Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
generic drug manufacturers
|
| gptkbp:approvedBy |
2017
2022 |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:dateEnacted |
2012
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:fullName |
gptkb:Generic_Drug_User_Fee_Amendments
|
| http://www.w3.org/2000/01/rdf-schema#label |
GDUFA
|
| gptkbp:purpose |
to speed the review of generic drug applications
to ensure timely access to safe, high-quality generic drugs |
| gptkbp:reauthorizationName |
GDUFA II
GDUFA III |
| gptkbp:relatedTo |
gptkb:Prescription_Drug_User_Fee_Act
|
| gptkbp:requires |
user fees from generic drug industry
|
| gptkbp:bfsParent |
gptkb:Generic_Drug_User_Fee_Amendments
|
| gptkbp:bfsLayer |
7
|