Title I: Abbreviated New Drug Applications
GPTKB entity
Statements (18)
Predicate | Object |
---|---|
gptkbp:instanceOf |
gptkb:legislation
|
gptkbp:affects |
pharmaceutical manufacturers
brand-name drug companies generic drug companies |
gptkbp:alsoKnownAs |
Hatch-Waxman Act Title I
|
gptkbp:amendedBy |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
gptkbp:dateEnacted |
1984
|
gptkbp:enables |
FDA approval of generics without duplicative clinical trials
|
gptkbp:enactedBy |
gptkb:United_States_Congress
|
gptkbp:establishes |
gptkb:Abbreviated_New_Drug_Application_(ANDA)
|
https://www.w3.org/2000/01/rdf-schema#label |
Title I: Abbreviated New Drug Applications
|
gptkbp:partOf |
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act
|
gptkbp:purpose |
to balance innovation and competition in pharmaceuticals
to streamline approval of generic drugs |
gptkbp:regulates |
generic drug approval
|
gptkbp:requires |
bioequivalence demonstration
|
gptkbp:bfsParent |
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act
|
gptkbp:bfsLayer |
8
|