All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-2162
Requests that absent new peer-reviewed studies or otherwise robust scientific or clinical evidence warranting such action, FDA take no action that would reduce patient access to mifepristone and/or increase the burdens associated with prescribing or dispensing mifepristone.
Documents
12
Comments
119
Key Dates
Comment Period OpensJul 7, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
119
Keywords
CDER
Citizen Petition
GenBioPro Inc
revoking
or suspending the 2000 approval of Mifeprex
adding new ETASU to the current REMS
reinstating former
ETASU that are not part of the current REMS
Data from Regulations.gov