Investigational New Drug application

URI: https://gptkb.org/entity/Investigational_New_Drug_application
GPTKB entity
Statements (44)
Predicate Object
gptkbp:instanceOf gptkb:law
submission
gptkbp:abbreviation IND application
gptkbp:application gptkb:biotechnology
gptkb:government_agency
academic investigator
gptkbp:category gptkb:United_States_federal_law
Pharmaceutical law
Clinical research
Drug regulation
gptkbp:contains toxicology data
clinical protocols
manufacturing information
preclinical data
investigator information
pharmacology data
gptkbp:country gptkb:United_States
gptkbp:enables Phase 1 clinical trial
Phase 2 clinical trial
Phase 3 clinical trial
gptkbp:firstRequired 1962
https://www.w3.org/2000/01/rdf-schema#label Investigational New Drug application
gptkbp:language English
gptkbp:legalBasis gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:21_CFR_Part_312
gptkbp:mayBePlacedOnHoldBy gptkb:FDA
gptkbp:mayBeWithdrawnBy promoter
gptkbp:purpose obtain authorization to administer an investigational drug to humans
gptkbp:regulates gptkb:Center_for_Biologics_Evaluation_and_Research
Center for Drug Evaluation and Research
gptkbp:relatedTo gptkb:New_Drug_Application
gptkb:Orphan_Drug_Act
Clinical trial
Compassionate use
Expanded access
Investigational device exemption
gptkbp:requires initiation of clinical trials in the United States
gptkbp:reviewedBy FDA reviewers
gptkbp:status active
terminated
inactive
gptkbp:YouTubeChannel gptkb:U.S._Food_and_Drug_Administration
gptkbp:bfsParent gptkb:New_Drug_Application
gptkbp:bfsLayer 7