Requests that the FDA Open a Docket, Hold a Part 15 Public Hearing Regarding the Off-Label Use of Estrogen in Natal Males for Gender Affirmation, and Consider Regulatory Action Including a Boxed Warning Under 21 C.F.R. § 201.80(e)
🏛 Food and Drug Administration (FDA)FDA-2025-P-7321
Documents
1
Total comments
2,075
731 awaiting analysis
Comment status
Open
Last activity
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In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
OtherDec 23, 2025
Citizen Petition from Lauren H. Schwartz, et al.No comment period💬 2,075 comments · 731 awaiting analysis