Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
FDA regulatory pathway
|
| gptkbp:alsoKnownAs |
ANDA pathway
|
| gptkbp:ANDAStandsFor |
gptkb:Abbreviated_New_Drug_Application
|
| gptkbp:appliesTo |
generic drugs
|
| gptkbp:approvedBy |
1984
|
| gptkbp:compatibleWith |
clinical efficacy studies
|
| gptkbp:contrastsWith |
reference listed drug
|
| gptkbp:describedBy |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:enables |
market entry of generics
|
| gptkbp:establishedBy |
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act
|
| https://www.w3.org/2000/01/rdf-schema#label |
505(j) pathway
|
| gptkbp:purpose |
approval of generic drugs
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
gptkb:Abbreviated_New_Drug_Application
bioequivalence studies |
| gptkbp:section |
Section 505(j) of the FD&C Act
|
| gptkbp:bfsParent |
gptkb:Abbreviated_New_Drug_Applications
|
| gptkbp:bfsLayer |
6
|