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)
|
| 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
|
| https://www.w3.org/2000/01/rdf-schema#label |
Title I: Abbreviated New Drug Applications
|