Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:appliesTo |
drugs
|
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:benefit |
eligibility for Accelerated Approval
eligibility for Priority Review more frequent meetings with FDA rolling review of application |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:criteria |
fills unmet medical need
treats serious conditions |
| https://www.w3.org/2000/01/rdf-schema#label |
Fast Track designation
|
| gptkbp:introduced |
gptkb:Food_and_Drug_Administration_Modernization_Act_of_1997
|
| gptkbp:introducedIn |
1997
|
| gptkbp:purpose |
expedite development and review of drugs
|
| gptkbp:relatedTo |
gptkb:Breakthrough_Therapy_designation
Accelerated Approval Priority Review |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|