# OnCo record fdasia-2012 (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/fdasia-2012/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "fdasia-2012" ;
  schema:name "FDASIA 2012 and the origins of the expedited programmes"@en ;
  schema:alternateName "FDASIA"@en, "Food and Drug Administration Safety and Innovation Act"@en, "FDAMA"@en, "Food and Drug Administration Modernization Act"@en, "Prescription Drug User Fee Act"@en, "PDUFA"@en ;
  schema:description "The 2012 US law that created Breakthrough Therapy designation and made the paediatric study laws permanent, sitting on top of the 1992 user-fee law that gave the FDA review deadlines and the 1997 law that created Fast Track."@en ;
  schema:url <https://onco.cc/terms/fdasia-2012/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Safety_and_Innovation_Act> ;
  schema:citation <https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Safety_and_Innovation_Act>, <https://www.congress.gov/bill/112th-congress/senate-bill/3187>, <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics> ;
  onco:tag "law", "us" ;
  onco:related <https://onco.cc/terms/breakthrough-designation/>, <https://onco.cc/terms/fast-track-rmat/>, <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/bla-nda/>, <https://onco.cc/terms/fdca/>, <https://onco.cc/terms/fdora-2022/>, <https://onco.cc/terms/bpca-prea/>, <https://onco.cc/terms/real-time-oncology-review/>, <https://onco.cc/terms/21st-century-cures-act/> ;
  onco:institutions <https://onco.cc/institutions/fda-oce/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .