Biosimilar User Fee Act (BsUFA)
GPTKB entity
Statements (15)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
biosimilar biological products
|
| gptkbp:dateEnacted |
2012
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| https://www.w3.org/2000/01/rdf-schema#label |
Biosimilar User Fee Act (BsUFA)
|
| gptkbp:partOf |
Food and Drug Administration Safety and Innovation Act (FDASIA)
|
| gptkbp:purpose |
to authorize FDA to collect fees for biosimilar biological product applications
|
| gptkbp:relatedTo |
gptkb:Generic_Drug_User_Fee_Amendments_(GDUFA)
gptkb:Prescription_Drug_User_Fee_Act_(PDUFA) |
| gptkbp:renewable |
gptkb:BsUFA_II
gptkb:BsUFA_III |
| gptkbp:shortName |
gptkb:BsUFA
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|