Prescription Drug User Fee Act (PDUFA)
GPTKB entity
Statements (18)
| 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 applications
|
| gptkbp:category |
Healthcare law
Pharmaceutical regulation |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:dateEnacted |
1992
|
| gptkbp:effect |
accelerated drug review process
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| https://www.w3.org/2000/01/rdf-schema#label |
Prescription Drug User Fee Act (PDUFA)
|
| gptkbp:latestRenewal |
PDUFA VII (2022-2027)
|
| gptkbp:purpose |
to allow FDA to collect fees from drug manufacturers to fund new drug approval process
|
| gptkbp:relatedTo |
Biologics Price Competition and Innovation Act
FDA Modernization Act |
| gptkbp:renewable |
multiple times
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|