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url: https://www.federalregister.gov/documents/2026/07/28/2026-15186/cancer-clinical-trial-eligibility-criteria-washout-periods-and-concomitant-medications-guidance-for
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canonical_url: https://www.federalregister.gov/documents/2026/07/28/2026-15186/cancer-clinical-trial-eligibility-criteria-washout-periods-and-concomitant-medications-guidance-for
source: us-federal-register
category: government/us
category_raw: Notice
country: us
region: us
tags: []
lang: en
published_at: '2026-07-28T00:00:00Z'
fetched_at: '2026-07-28T09:01:34.002135Z'
updated_at: '2026-07-28T09:12:19Z'
status: published
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attribution: 'Source: Office of the Federal Register, National Archives and Records
  Administration'
license_rule: source:us-federal-register
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:
  Washout Periods and Concomitant Medications." 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 Specifically, this draft guidance includes recommendations
  regarding the appropriate use of washout periods and concomitant medication exclusions.
  This guidance finalizes the draft guidance of the same title issued on April 26,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:
  Washout Periods and Concomitant Medications." 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 Specifically, this draft guidance includes recommendations
  regarding the appropriate use of washout periods and concomitant medication exclusions.
  This guidance finalizes the draft guidance of the same title issued on April 26,
  2024.'
provenance:
  doc_id: 2026-15186
  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: Washout Periods and Concomitant
  Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators;
  Availability'
---

# Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; 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: Washout Periods and Concomitant Medications." 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 draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. 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: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability](https://www.federalregister.gov/documents/2026/07/28/2026-15186/cancer-clinical-trial-eligibility-criteria-washout-periods-and-concomitant-medications-guidance-for) — published 2026-07-28T00:00:00Z