|
gptkbp:instanceOf
|
submission
|
|
gptkbp:abbreviation
|
gptkb:NDA
|
|
gptkbp:appliesTo
|
new drugs
|
|
gptkbp:category
|
drug approval process
|
|
gptkbp:country
|
gptkb:United_States
|
|
gptkbp:format
|
gptkb:electronic_Common_Technical_Document
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
New Drug Application
|
|
gptkbp:includes
|
safety data
clinical trial data
efficacy data
labeling information
manufacturing information
preclinical data
|
|
gptkbp:introducedIn
|
1938
|
|
gptkbp:legalBasis
|
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
|
gptkbp:purpose
|
request approval to market a new pharmaceutical in the United States
|
|
gptkbp:regulates
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:relatedTo
|
gptkb:Investigational_New_Drug_application
gptkb:Abbreviated_New_Drug_Application
|
|
gptkbp:requires
|
marketing approval in the United States
|
|
gptkbp:reviewedBy
|
Center for Drug Evaluation and Research
|
|
gptkbp:bfsParent
|
gptkb:Abbreviated_New_Drug_Applications
gptkb:Investigational_New_Drug_applications
gptkb:Drug_Development
|
|
gptkbp:bfsLayer
|
6
|