Accelerated Approval pathway
GPTKB entity
Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory pathway
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
serious or life-threatening diseases
|
| gptkbp:approvalBasedOn |
surrogate endpoints
|
| gptkbp:cause |
withdrawal if confirmatory trials fail
|
| gptkbp:criteria |
drugs that address unmet medical needs
|
| gptkbp:establishedIn |
1992
|
| https://www.w3.org/2000/01/rdf-schema#label |
Accelerated Approval pathway
|
| gptkbp:purpose |
expedite approval of drugs for serious conditions
|
| gptkbp:regulationCited |
21 CFR 314.500
21 CFR 601.40 |
| gptkbp:relatedTo |
gptkb:Breakthrough_Therapy_designation
gptkb:Fast_Track_designation Priority Review |
| gptkbp:requires |
post-marketing confirmatory trials
labeling to reflect accelerated approval status |
| gptkbp:usedFor |
oncology drugs
rare diseases |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|