Section 505 of the Federal Food, Drug, and Cosmetic Act
GPTKB entity
Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:amendedBy |
gptkb:Food_and_Drug_Administration_Modernization_Act_of_1997
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act_of_1984 |
| gptkbp:appliesTo |
over-the-counter drugs
prescription drugs |
| gptkbp:codifiedIn |
gptkb:21_U.S.C._§_355
|
| gptkbp:dateEnacted |
1938
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
New Drug Application (NDA) process
|
| https://www.w3.org/2000/01/rdf-schema#label |
Section 505 of the Federal Food, Drug, and Cosmetic Act
|
| gptkbp:partOf |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:providesFor |
gptkb:Abbreviated_New_Drug_Application_(ANDA)
approval of generic drugs |
| gptkbp:regulates |
approval of new drugs
|
| gptkbp:requires |
demonstration of drug safety and efficacy
|
| gptkbp:subjectOf |
regulatory guidance by FDA
|
| gptkbp:bfsParent |
gptkb:21_U.S.C._355
gptkb:21_U.S.C._§_355 |
| gptkbp:bfsLayer |
8
|