Investigational New Drug applications

GPTKB entity

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