Health and Human Services Department, Food and Drug Administration
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 Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-D-1376] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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 Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024. DATES: The announcement of the guidance is published in the Federal Register on July 28, 2026. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted …
Other Federal Register documents from the same docket.
Citation: 91 FR 47247
