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
|
| 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
|
| https://www.w3.org/2000/01/rdf-schema#label |
Prescription Drug User Fee Act
|