Nonrulemaking

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)

Documents
2
Total comments
10,031
28 awaiting analysis
Comment status
Open
Last activity
Jul 29, 2026
In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

📄 Primary document
OtherJun 18, 2026
Interim Response
No comment period
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