breakthrough therapy designation
GPTKB entity
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Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:appliesTo |
drugs for serious or life-threatening conditions
|
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:benefit |
priority review
organizational commitment involving senior managers increased FDA guidance rolling review |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:criteria |
preliminary clinical evidence indicates substantial improvement over existing therapies
|
| https://www.w3.org/2000/01/rdf-schema#label |
breakthrough therapy designation
|
| gptkbp:introduced |
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
|
| gptkbp:introducedIn |
2012
|
| gptkbp:purpose |
expedite development and review of drugs
|
| gptkbp:relatedTo |
gptkb:accelerated_approval
gptkb:fast_track_designation priority review designation |
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
4
|