# OnCo record fdca (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/fdca/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "fdca" ;
  schema:name "Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments"@en ;
  schema:alternateName "FD&C Act"@en, "FDCA"@en, "Federal Food, Drug and Cosmetic Act"@en, "Kefauver-Harris"@en, "Kefauver-Harris Amendments"@en, "Drug Efficacy Amendment"@en, "substantial evidence standard"@en, "adequate and well-controlled investigations"@en ;
  schema:description "The 1938 US law that makes a company prove a medicine is safe before selling it, and the 1962 amendments that added the requirement to prove it works, which is why every cancer drug approval rests on controlled trials."@en ;
  schema:url <https://onco.cc/terms/fdca/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act> ;
  schema:citation <https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act>, <https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act>, <https://en.wikipedia.org/wiki/Kefauver%E2%80%93Harris_Amendment> ;
  onco:tag "law", "us" ;
  onco:related <https://onco.cc/terms/fdora-2022/>, <https://onco.cc/terms/fdasia-2012/>, <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/bla-nda/>, <https://onco.cc/terms/full-approval/>, <https://onco.cc/terms/common-rule/>, <https://onco.cc/terms/declaration-of-helsinki/>, <https://onco.cc/terms/regulatory-agencies/>, <https://onco.cc/terms/clinical-trial/> ;
  onco:institutions <https://onco.cc/institutions/fda-oce/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-design/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .