Breakthrough Therapy Designation
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory designation
|
| gptkbp:abbreviation |
gptkb:BTD
|
| gptkbp:appliesTo |
biologics
drugs |
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:benefit |
priority review
increased FDA guidance rolling review organizational commitment involving senior FDA 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 |
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 for serious conditions
|
| gptkbp:regulates |
active
|
| gptkbp:relatedTo |
gptkb:Fast_Track_designation
Accelerated Approval Priority Review |
| gptkbp:bfsParent |
gptkb:Friends_of_Cancer_Research
gptkb:COMP360_(psilocybin_therapy) |
| gptkbp:bfsLayer |
8
|