Statements (32)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
|
| gptkbp:application |
pharmaceutical companies
|
| gptkbp:contains |
safety data
clinical trial data efficacy data labeling information manufacturing information preclinical data |
| gptkbp:country |
gptkb:United_States
|
| https://www.w3.org/2000/01/rdf-schema#label |
New Drug Applications (NDA)
|
| gptkbp:includes |
patent information
proposed labeling risk evaluation and mitigation strategies (REMS) user fee payment |
| gptkbp:introducedIn |
1938
|
| gptkbp:legalBasis |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:purpose |
obtain approval to market a new pharmaceutical in the United States
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:Abbreviated_New_Drug_Application_(ANDA)
Biologics License Application (BLA) |
| gptkbp:requires |
new chemical entities
new indications for approved drugs |
| gptkbp:result |
approval
complete response letter refusal to file |
| gptkbp:reviewedBy |
Center for Drug Evaluation and Research
|
| gptkbp:reviewTime |
6 months priority review
typically 10 months standard review |
| gptkbp:YouTubeChannel |
gptkb:newspaper
electronic |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|