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The FDA is reopening the comment period for public input on the proposed rule for an additional 60 days, ending on October 2, 2026.
This change is significant as it alters the regulatory definitions for demographic data in multiple regulations, thus impacting how data is reported and collected in the context of human and veterinary drugs, biologics, and devices.
MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.
Regulatory Intelligence Lead
Review before 2026-10-02.
Global replacement of 'gender' with 'sex' in Title 21 CFR sections, affecting regulatory definitions for demographic data in human and veterinary drug, biologic, and device regulations.
MAHs and sponsors should monitor this rule for impacts on official reporting forms and database fields. While E2B(R3) already uses 'sex', alignment of US national regulations may require updates to SOPs or internal forms that currently reference 'gender' based on previous CFR wording. Regulatory affairs teams should review the affected sections to ensure compliance with the updated biological terminology.
MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.
The FDA announced it is reopening the comment period for a proposed rule aimed at modifying terminology in Title 21 of the CFR, specifically to replace instances of the term 'gender' with 'sex' or remove the term entirely. This update aligns with Executive Order 14168 and impacts regulations regarding patient demographics, particularly in safety reporting and clinical trial data collection. Stakeholders have until October 2, 2026, to submit comments.
What changed: The FDA is reopening the comment period for public input on the proposed rule for an additional 60 days, ending on October 2, 2026.
Why it matters: This change is significant as it alters the regulatory definitions for demographic data in multiple regulations, thus impacting how data is reported and collected in the context of human and veterinary drugs, biologics, and devices.
Practical implication: MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.
Published from the Firecrawl policy change extraction pipeline.
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