Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:alsoKnownAs |
gptkb:Section_505_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:amendedBy |
gptkb:Food_and_Drug_Administration_Modernization_Act
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act |
| gptkbp:appliesTo |
generic drugs
brand-name drugs human drugs |
| gptkbp:basisFor |
gptkb:505(b)(2)_application
gptkb:505(j)_application gptkb:Abbreviated_New_Drug_Application_(ANDA) |
| gptkbp:citation |
safety and effectiveness standards
|
| gptkbp:dateEnacted |
1938
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 U.S.C. § 355
|
| gptkbp:partOf |
gptkb:Title_21_of_the_United_States_Code
|
| gptkbp:referencedIn |
gptkb:Orange_Book
|
| gptkbp:regulates |
approval of new drugs
|
| gptkbp:requires |
gptkb:New_Drug_Application
clinical trial data labeling information FDA approval before marketing |
| gptkbp:bfsParent |
gptkb:Title_21_of_the_United_States_Code
gptkb:Hatch-Waxman_Act |
| gptkbp:bfsLayer |
7
|