Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory framework
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
nonprescription drugs
|
| gptkbp:compatibleWith |
prescription drugs
|
| gptkbp:contains |
final monographs
proposed monographs tentative final monographs therapeutic categories |
| gptkbp:describes |
labeling requirements
active ingredients conditions for safe use dosage forms |
| gptkbp:enables |
marketing without pre-approval
standardized drug approval |
| gptkbp:establishedBy |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:firstIssueDate |
1972
|
| gptkbp:goal |
ensure drug safety
ensure drug effectiveness |
| https://www.w3.org/2000/01/rdf-schema#label |
OTC monograph
|
| gptkbp:regulates |
over-the-counter drugs
|
| gptkbp:subject |
public comment
scientific review |
| gptkbp:updated |
gptkb:Over-the-Counter_Monograph_User_Fee_Act_(OMUFA)
FDA rulemaking |
| gptkbp:usedIn |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
5
|