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url: https://www.federalregister.gov/documents/2026/07/28/2026-15185/cancer-clinical-trial-eligibility-criteria-performance-status-guidance-for-industry-institutional
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canonical_url: https://www.federalregister.gov/documents/2026/07/28/2026-15185/cancer-clinical-trial-eligibility-criteria-performance-status-guidance-for-industry-institutional
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category_raw: Notice
country: us
region: us
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lang: en
published_at: '2026-07-28T00:00:00Z'
fetched_at: '2026-07-28T09:01:34.010882Z'
updated_at: '2026-07-28T09:12:19Z'
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attribution: 'Source: Office of the Federal Register, National Archives and Records
  Administration'
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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 entitled "Cancer Clinical Trial
  Eligibility Criteria: Performance Status." 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 regarding expanding
  eligibility criteria to include patients with a wider range of performance status.
  This guidance finalizes the draft guidance of the same title issued on April 26,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 entitled "Cancer Clinical Trial
  Eligibility Criteria: Performance Status." 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 regarding expanding
  eligibility criteria to include patients with a wider range of performance status.
  This guidance finalizes the draft guidance of the same title issued on April 26,
  2024.'
provenance:
  doc_id: 2026-15185
  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:
- name: PerformanceBoost
  type: UNKNOWN
- name: xcancel.com/HedgieMarkets/status/2081534588485296565
  type: artifact
key_facts: []
related: []
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title: 'Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for
  Industry, Institutional Review Boards, and Clinical Investigators; Availability'
---

# Cancer Clinical Trial Eligibility Criteria: Performance Status; 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 entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." 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 regarding expanding eligibility criteria to include patients with a wider range of performance status. 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: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability](https://www.federalregister.gov/documents/2026/07/28/2026-15185/cancer-clinical-trial-eligibility-criteria-performance-status-guidance-for-industry-institutional) — published 2026-07-28T00:00:00Z