Statements (14)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:appliesTo |
new drug applications
|
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:criteria |
treats serious conditions
provides significant improvement in safety or effectiveness |
| https://www.w3.org/2000/01/rdf-schema#label |
Priority Review designation
|
| gptkbp:purpose |
expedite review of drugs that offer significant improvements
|
| gptkbp:relatedTo |
gptkb:Breakthrough_Therapy_designation
gptkb:Fast_Track_designation Accelerated Approval |
| gptkbp:reviewTime |
6 months
|
| gptkbp:standardReviewTime |
10 months
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|