# OnCo record idea-reg-conditional-approval-sunset (idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/ideas/idea-reg-conditional-approval-sunset/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-reg-conditional-approval-sunset" ;
  schema:name "Conditional approvals that lapse automatically if the confirmatory trial is late"@en ;
  schema:description "Drugs given accelerated or conditional approval on surrogate endpoints have often stayed on the market for years after the confirmatory trial stalled or failed. The approval would lapse automatically if the sponsor missed agreed enrolment milestones or the readout date, unless an independent panel granted a documented extension."@en ;
  schema:url <https://onco.cc/ideas/idea-reg-conditional-approval-sunset/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis> ;
  onco:related <https://onco.cc/collections/fda-approvals/> ;
  onco:terms <https://onco.cc/terms/accelerated-approval/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-regulatory-fragmentation/>, <https://onco.cc/bottlenecks/b-incentive-misalignment/> .