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) | Federal Regulations · Congress.wiki

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

Comments

Description

Open

Key Dates

Comment Period OpensDec 23, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Acknowledgement Letter from FDA DMB to Lauren H. Schwartz, et al.	Dec 23, 2025	--

Comment Statistics

Total Comments

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