Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:alsoKnownAs |
Hatch-Waxman Act Section 505(j)
|
| gptkbp:amendedBy |
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act_of_1984
|
| gptkbp:appliesTo |
human drugs
|
| gptkbp:codifiedIn |
gptkb:Title_21_of_the_United_States_Code
|
| gptkbp:concerns |
generic drugs
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
ANDA process
|
| gptkbp:excludes |
new clinical investigations
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 U.S.C. § 355(j)
|
| gptkbp:partOf |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:providesFor |
patent certification
180-day exclusivity for first generic filer |
| gptkbp:regulates |
gptkb:Abbreviated_New_Drug_Application
|
| gptkbp:requires |
labeling information
bioequivalence data |
| gptkbp:bfsParent |
gptkb:Hatch-Waxman_Amendments
|
| gptkbp:bfsLayer |
8
|