Statements (14)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:appliesTo |
drugs for serious conditions
|
| 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:criteria |
unmet medical need
|
| https://www.w3.org/2000/01/rdf-schema#label |
fast track designation
|
| gptkbp:introduced |
gptkb:Food_and_Drug_Administration_Modernization_Act
|
| gptkbp:introducedIn |
1997
|
| gptkbp:purpose |
expedite development and review of drugs
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
4
|