Statements (23)
Predicate | Object |
---|---|
gptkbp:instanceOf |
gptkb:United_States_federal_law
|
gptkbp:alsoKnownAs |
Drug Efficacy Amendment
|
gptkbp:amendedBy |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
gptkbp:authority |
gptkb:U.S._Food_and_Drug_Administration
|
gptkbp:category |
Pharmaceutical law
1962 in American law |
gptkbp:dateEnacted |
1962
|
gptkbp:enactedBy |
gptkb:United_States_Congress
|
gptkbp:establishes |
requirement for informed consent in clinical trials
|
https://www.w3.org/2000/01/rdf-schema#label |
Kefauver Harris Amendment
|
gptkbp:namedAfter |
gptkb:Estes_Kefauver
Oren Harris |
gptkbp:regulates |
pharmaceutical industry
|
gptkbp:requires |
drug advertising to disclose effectiveness
drug advertising to disclose side effects proof of drug efficacy proof of drug safety |
gptkbp:response |
gptkb:thalidomide_tragedy
|
gptkbp:signedBy |
gptkb:John_F._Kennedy
|
gptkbp:bfsParent |
gptkb:Drug_Amendments_of_1962
gptkb:Public_Law_75-415 gptkb:Food,_Drug,_and_Cosmetic_Act |
gptkbp:bfsLayer |
7
|