{
 "@context": "https://schema.org",
 "@type": "DefinedTerm",
 "@id": "https://wulfkaal.github.io/entities/fda",
 "identifier": "kaal:entity:fda",
 "name": "Fda",
 "termCode": "fda",
 "inDefinedTermSet": {
  "@id": "https://wulfkaal.github.io/entities/index.json"
 },
 "author": {
  "@type": "Person",
  "name": "Wulf A. Kaal",
  "identifier": "https://orcid.org/0000-0003-0757-275X"
 },
 "dateModified": "2026-07-29",
 "canonicalForm": "https://wulfkaal.github.io/entities/fda.md",
 "sha256": "8714c35121b0f11397bbf3b3abe19e14de77a94ca91b107d26693687e9b86b8b",
 "additionalProperty": [
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   "@type": "PropertyValue",
   "name": "status",
   "value": "derived"
  },
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   "@type": "PropertyValue",
   "name": "claim_count",
   "value": 2
  },
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   "value": 1
  },
  {
   "@type": "PropertyValue",
   "name": "year_span",
   "value": [
    "2013",
    "2013"
   ]
  },
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  }
 ],
 "subjectOf": [
  {
   "@type": "Claim",
   "@id": "https://wulfkaal.github.io/claims/2317580-012",
   "identifier": "kaal:claim:2317580-012",
   "text": "CIA penalties reach individuals as well as entities: firms supervised by the FDA may not employ persons dismissed for CIA violations, and the careers of pharmaceutical directors and officers prosecuted over CIA violations can be severely damaged.",
   "abstract": "For instance, companies subject to supervision by the Food and Drug Administration (FDA) may not employ individuals who were",
   "citation": "Wulf A. Kaal, Elizabeth R. Malay, The Role of Corporate Integrity Agreements in the Expansion of Fiduciary Duties (2013). SSRN: https://ssrn.com/abstract=2317580",
   "datePublished": "2013",
   "claim_type": "empirical",
   "confidence": "evidenced",
   "is_failure_mode": false,
   "scope_conditions": [
    "FDA regulated companies",
    "pharmaceutical industry directors and officers"
   ],
   "source_pdf_sha256": "50973e1e820aef47a4e7ffdbdcb513d03f1845643fcf4fa5910e9528a0b7dac2",
   "status": "current"
  },
  {
   "@type": "Claim",
   "@id": "https://wulfkaal.github.io/claims/2317580-034",
   "identifier": "kaal:claim:2317580-034",
   "text": "Abbott Labs set the stage for the Pfizer holding: although Abbott's Voluntary Compliance Plan was not a CIA, the Seventh Circuit used it as evidence that the directors knew of and should have stopped noncompliant activities.",
   "abstract": "Although the Voluntary Compliance Plan was not a CIA, the Seventh Circuit used it as evidence that the directors knew of and should have stopped noncompliant activities.",
   "citation": "Wulf A. Kaal, Elizabeth R. Malay, The Role of Corporate Integrity Agreements in the Expansion of Fiduciary Duties (2013). SSRN: https://ssrn.com/abstract=2317580",
   "datePublished": "2013",
   "claim_type": "empirical",
   "confidence": "evidenced",
   "is_failure_mode": false,
   "scope_conditions": [
    "In re Abbott Laboratories Derivative Shareholders Litigation",
    "a six year history of documented FDA noncompliance"
   ],
   "source_pdf_sha256": "50973e1e820aef47a4e7ffdbdcb513d03f1845643fcf4fa5910e9528a0b7dac2",
   "status": "current"
  }
 ],
 "description": "2 claims in the published works of Wulf A. Kaal carry the concept tag 'fda'. Derived node: a roster, not an adjudicated definition."
}