All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-5434
Requests that the FDA revoke its actions to approve the Abbreviate New Drug Application 216616, a generic version of Mifepristone, and modify the associated regimen (including the REMS) until the agency determines that it has complied with the various states’ water quality standards as compelled by the CWA
Documents
3
Comments
3
Description
Open
Key Dates
Comment Period OpensOct 17, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
3
Keywords
CDER
Citizen Petition
Students for Life of America
Requests that the FDA revoke its actions to
approve the Abbreviate New Drug Application
216616, a generic version of Mifepristone, and
modify the associated regimen
(including the REMS) until the agency determines
Data from Regulations.gov