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url: https://www.federalregister.gov/documents/2026/07/28/2026-15187/cancer-clinical-trial-eligibility-criteria-laboratory-values-guidance-for-industry-institutional
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canonical_url: https://www.federalregister.gov/documents/2026/07/28/2026-15187/cancer-clinical-trial-eligibility-criteria-laboratory-values-guidance-for-industry-institutional
source: us-federal-register
category: government/us
category_raw: Notice
country: us
region: us
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lang: en
published_at: '2026-07-28T00:00:00Z'
fetched_at: '2026-07-28T09:01:33.993399Z'
updated_at: '2026-07-28T09:12:19Z'
status: published
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attribution: 'Source: Office of the Federal Register, National Archives and Records
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summary: 'The Food and Drug Administration (FDA, the Agency, or we) is announcing
  the availability of a final guidance for industry, institutional review boards (IRBs),
  and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria:
  Laboratory Values." This guidance is one in a series of guidances that provide recommendations
  regarding eligibility criteria for clinical trials of investigational drugs regulated
  by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics
  Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance
  includes recommendations for selecting appropriate laboratory values as trial eligibility
  criteria to avoid unjustified exclusions of trial participants. This guidance finalizes
  the draft guidance of the same title issued on April 26, 2024.'
summary_source: official
summary_en: 'The Food and Drug Administration (FDA, the Agency, or we) is announcing
  the availability of a final guidance for industry, institutional review boards (IRBs),
  and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria:
  Laboratory Values." This guidance is one in a series of guidances that provide recommendations
  regarding eligibility criteria for clinical trials of investigational drugs regulated
  by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics
  Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance
  includes recommendations for selecting appropriate laboratory values as trial eligibility
  criteria to avoid unjustified exclusions of trial participants. This guidance finalizes
  the draft guidance of the same title issued on April 26, 2024.'
provenance:
  doc_id: 2026-15187
  doc_id_scheme: fr_docnum
  issuer:
  - Health and Human Services Department
  - Food and Drug Administration
  doc_type: Notice
  subtype: null
  action: Notice of availability.
  significant: null
entities: []
key_facts: []
related: []
related_auto: []
title: 'Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for
  Industry, Institutional Review Boards, and Clinical Investigators; Availability'
---

# Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability

## TL;DR
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial participants. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.

## Key Points
- (なし)

## Details
(本文なし。リンク先参照)

## Source
元記事: [Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability](https://www.federalregister.gov/documents/2026/07/28/2026-15187/cancer-clinical-trial-eligibility-criteria-laboratory-values-guidance-for-industry-institutional) — published 2026-07-28T00:00:00Z