Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:alsoKnownAs |
gptkb:Kefauver_Harris_Amendment
|
| gptkbp:amendedBy |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:appliesTo |
new drugs
|
| gptkbp:dateEnacted |
1962
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:established |
requirement for adequate and well-controlled studies
|
| gptkbp:grantsAuthorityTo |
gptkb:U.S._Food_and_Drug_Administration
|
| https://www.w3.org/2000/01/rdf-schema#label |
Drug Amendments of 1962
|
| gptkbp:powers |
regulation of prescription drugs
|
| gptkbp:purpose |
to ensure drug efficacy and safety
|
| gptkbp:regulates |
drug advertising
|
| gptkbp:requires |
informed consent in clinical trials
proof of effectiveness before drug approval |
| gptkbp:response |
gptkb:thalidomide_tragedy
|
| gptkbp:signedBy |
gptkb:John_F._Kennedy
|
| gptkbp:bfsParent |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:bfsLayer |
6
|