Prescription Drug User Fee Act
GPTKB entity
Statements (24)
Predicate | Object |
---|---|
gptkbp:instanceOf |
gptkb:United_States_federal_law
|
gptkbp:abbreviation |
PDUFA
|
gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
gptkbp:appliesTo |
prescription drug manufacturers
|
gptkbp:category |
gptkb:United_States_federal_health_legislation
Pharmaceutical regulation in the United States |
gptkbp:dateEnacted |
1992
|
gptkbp:enactedBy |
gptkb:United_States_Congress
|
https://www.w3.org/2000/01/rdf-schema#label |
Prescription Drug User Fee Act
|
gptkbp:purpose |
to allow FDA to collect fees from drug manufacturers to fund new drug approval process
|
gptkbp:relatedTo |
drug approval process
FDA user fees |
gptkbp:renewable |
1997
2002 2007 2012 2017 2022 |
gptkbp:signedBy |
gptkb:George_H._W._Bush
|
gptkbp:bfsParent |
gptkb:Biosimilar_User_Fee_Act
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007 gptkb:Generic_Drug_User_Fee_Amendments gptkb:Medical_Device_User_Fee_Amendments |
gptkbp:bfsLayer |
7
|