FDA Breakthrough Therapy designation
GPTKB entity
Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:abbreviation |
gptkb:BTD
|
| gptkbp:appliesTo |
drugs for serious or life-threatening conditions
|
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:benefit |
priority review
increased FDA guidance rolling review organizational commitment from FDA senior managers |
| 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 |
FDA 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:Fast_Track_designation
Accelerated Approval Priority Review |
| gptkbp:bfsParent |
gptkb:FDA_Breakthrough_Device_designation
|
| gptkbp:bfsLayer |
8
|