Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory pathway
|
| gptkbp:administeredBy |
gptkb:Center_for_Biologics_Evaluation_and_Research
Center for Drug Evaluation and Research |
| gptkbp:appliesTo |
drugs for unmet medical needs
|
| gptkbp:can_be_withdrawn_if |
confirmatory trials fail
|
| gptkbp:criteria |
based on surrogate endpoints
|
| gptkbp:enables |
earlier patient access to therapies
|
| https://www.w3.org/2000/01/rdf-schema#label |
accelerated approval
|
| gptkbp:introduced |
1992
|
| gptkbp:purpose |
expedite approval of drugs for serious conditions
|
| gptkbp:regulates |
biologics
small molecule drugs |
| gptkbp:relatedTo |
gptkb:breakthrough_therapy_designation
gptkb:fast_track_designation priority review |
| gptkbp:requires |
evidence of effect on surrogate endpoint
post-marketing confirmatory trials |
| gptkbp:used_in |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
4
|