Food and Drug Administration Amendments Act Section 801
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:alsoKnownAs |
gptkb:FDAAA_801
|
| gptkbp:appliesTo |
interventional studies of biologics
interventional studies of devices interventional studies of drugs |
| gptkbp:codifiedIn |
gptkb:42_U.S.C._§_282(j)
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:established |
legal requirements for ClinicalTrials.gov
|
| gptkbp:goal |
increase transparency of clinical research
improve public access to clinical trial information |
| https://www.w3.org/2000/01/rdf-schema#label |
Food and Drug Administration Amendments Act Section 801
|
| gptkbp:partOf |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:penalty |
monetary fines
withholding of NIH grant funds |
| gptkbp:regulates |
clinical trial registration
clinical trial results reporting |
| gptkbp:requires |
registration of applicable clinical trials
submission of summary results |
| gptkbp:startDate |
September 27, 2007
|
| gptkbp:subjectOf |
gptkb:Final_Rule_42_CFR_Part_11
|
| gptkbp:bfsParent |
gptkb:FDAAA_801
|
| gptkbp:bfsLayer |
6
|