|
gptkbp:instanceOf
|
gptkb:legislation
|
|
gptkbp:abbreviation
|
IND regulations
|
|
gptkbp:administeredBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:appliesTo
|
gptkb:institutional_review_boards
investigators conducting clinical trials
sponsors of clinical investigations
|
|
gptkbp:country
|
gptkb:United_States
|
|
gptkbp:covers
|
protocol amendments
expanded access to investigational drugs
recordkeeping
safety reporting
inspection of records
requirements for IND submission
clinical holds
withdrawal of INDs
|
|
gptkbp:enforcedBy
|
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
21 CFR Part 312
|
|
gptkbp:language
|
English
|
|
gptkbp:legalCitation
|
21 CFR §312
|
|
gptkbp:partOf
|
gptkb:Title_21_of_the_Code_of_Federal_Regulations
|
|
gptkbp:purpose
|
to govern the use of investigational new drugs in humans
|
|
gptkbp:regulates
|
Investigational New Drug Application
|
|
gptkbp:startDate
|
1987
|
|
gptkbp:updated
|
periodically
|
|
gptkbp:bfsParent
|
gptkb:Investigational_New_Drug_applications
|
|
gptkbp:bfsLayer
|
6
|