FDA adverse-event reporting forms cut the Gender field and keep only Male/Female "Sex"
- Date
- Actor
- Health and Human Services Department, Food and Drug Administration
- Agency
- Food and Drug Administration (FDA)
- Type
- Data/website removal
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.