Generic Drug User Fee Amendments (GDUFA)
GPTKB entity
Statements (19)
| 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 industry
|
| gptkbp:approvedBy |
2017
2022 |
| gptkbp:dateEnacted |
2012
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| https://www.w3.org/2000/01/rdf-schema#label |
Generic Drug User Fee Amendments (GDUFA)
|
| gptkbp:partOf |
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
|
| gptkbp:purpose |
to speed access to safe and effective generic drugs
to enhance FDA’s ability to regulate generic drugs to reduce costs to industry |
| gptkbp:relatedTo |
gptkb:Biosimilar_User_Fee_Act_(BsUFA)
gptkb:Prescription_Drug_User_Fee_Act_(PDUFA) |
| gptkbp:requires |
generic drug manufacturers to pay user fees
|
| gptkbp:website |
https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|