# OnCo record fdora-2022 (term). 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/terms/fdora-2022/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "fdora-2022" ;
  schema:name "FDORA 2022 accelerated approval reforms"@en ;
  schema:alternateName "FDORA"@en, "Food and Drug Omnibus Reform Act"@en, "Food and Drug Omnibus Reform Act of 2022"@en, "Consolidated Appropriations Act 2023 FDA provisions"@en, "accelerated approval reform"@en ;
  schema:description "A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails."@en ;
  schema:url <https://onco.cc/terms/fdora-2022/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://www.congress.gov/bill/117th-congress/house-bill/2617>, <https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program> ;
  onco:tag "law", "us" ;
  onco:related <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/full-approval/>, <https://onco.cc/terms/approval-withdrawal/>, <https://onco.cc/terms/confirmatory-trial/>, <https://onco.cc/terms/surrogate-endpoint/>, <https://onco.cc/terms/odac/>, <https://onco.cc/terms/fdca/>, <https://onco.cc/terms/fdasia-2012/>, <https://onco.cc/terms/project-optimus/> ;
  onco:institutions <https://onco.cc/institutions/fda-oce/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-design/>, <https://onco.cc/bottlenecks/b-incentive-misalignment/>, <https://onco.cc/bottlenecks/b-trial-diversity/> .