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Nonrulemaking
FDA
Open for Comments
FDA-2025-P-7321
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
3
Comments
10,031
Description
Open
Key Dates
Comment Period OpensDec 23, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
10,031
Keywords
CDER
Citizen Petition
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)
Data from Regulations.gov