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