FDA adverse-event reporting forms cut the Gender field and keep only Male/Female "Sex"

Data/website removalFDA

Date
Actor
Health and Human Services Department, Food and Drug Administration
Agency
Food and Drug Administration (FDA)
Type
Data/website removal
Section
SUPPLEMENT: ACTIONS MISSED BY EARLIER SWEEPS, JANUARY 2025 TO NOVEMBER 2026

Summary

90 FR 27029. OMB-submission notice for FDA's Adverse Event and Product Experience Reporting Program. In Section A and Section E of the forms, FDA proposes, based on EO 14168, to revise the Sex field to two options, Male and Female, and remove the Gender field. The edit repeats across the voluntary and mandatory reporting form revisions. Related to catalogue S11-020/S20-125 (FDA proposal to purge "gender" from Title 21) but a separate action.

Status

OMB submission; comments due July 25, 2025

As recorded in the data of . Check the sources for anything newer.

Sources