Investigational New Drug applications

URI: https://gptkb.org/entity/Investigational_New_Drug_applications
GPTKB entity
Statements (27)
Predicate Object
gptkbp:instanceOf gptkb:regulatory_process
gptkbp:abbreviation IND applications
gptkbp:country gptkb:United_States
gptkbp:filingDate gptkb:promoter
gptkb:biotechnology
gptkb:research_institute
gptkbp:includes clinical protocols
manufacturing information
preclinical data
investigator information
gptkbp:legalBasis gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:21_CFR_Part_312
gptkbp:purpose to obtain authorization to administer an investigational drug to humans
gptkbp:regulates gptkb:U.S._Food_and_Drug_Administration
gptkbp:relatedTo gptkb:drug
gptkb:New_Drug_Application
clinical research
drug development
gptkbp:requires clinical trials in the United States
gptkbp:reviewedBy gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research
gptkbp:status active
terminated
inactive
gptkbp:bfsParent gptkb:U.S._Food_and_Drug_Administration
gptkbp:bfsLayer 5
https://www.w3.org/2000/01/rdf-schema#label Investigational New Drug applications