Statements (18)
| 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 drug applications (ANDAs)
new drug applications (NDAs) |
| gptkbp:citation |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
process for FDA approval of new drugs
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 U.S.C. 355
|
| gptkbp:location |
United States Code, Title 21, Chapter 9, Subchapter V, Part A
|
| gptkbp:partOf |
gptkb:Title_21_of_the_United_States_Code
|
| gptkbp:regulates |
approval of new drugs
|
| gptkbp:requires |
clinical trial data submission
labeling information for drugs submission of safety and efficacy data |
| gptkbp:bfsParent |
gptkb:21_U.S.C._355(i)
|
| gptkbp:bfsLayer |
7
|