Request that FDA remove the Mifepristone Shared System REMS Program, including but not limited to the three ETASU requiring prescriber certification, pharmacy certification, and a patient agreement form | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-0377

Request that FDA remove the Mifepristone Shared System REMS Program, including but not limited to the three ETASU requiring prescriber certification, pharmacy certification, and a patient agreement form

Documents

Comments

246

Description

OPEN

Key Dates

Comment Period OpensFeb 4, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response Letter from FDA CDER to American College of Obstetricians and Gynecologists, Society of Family Planning and Society for Maternal-Fetal Medicine	Jul 28, 2025	--

Comment Statistics

Total Comments

246

Keywords

CDER

Citizen Petition

American College of

Obstetricians and Gynecologists

Society of Family Planning

Society for Maternal-Fetal Medicine

Request that FDA remove the

Mifepristone Shared System REMS Program,

Data from Regulations.gov