Breakthrough Therapy designation

GPTKB entity

Statements (20)
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 from FDA
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:introducedIn 2012
gptkbp:purpose expedite development and review of drugs for serious conditions
gptkbp:regulates gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
gptkbp:relatedTo gptkb:Fast_Track_designation
Accelerated Approval
Priority Review
gptkbp:bfsParent gptkb:U.S._Food_and_Drug_Administration_(FDA)
gptkbp:bfsLayer 7