All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-1305
Requests that the FDA require the immediate revision of all SSRI and SNRI antidepressant product labels (included branded and generic formulations) to warn of serious and severe risks
Documents
9
Comments
273
Description
Open
Key Dates
Comment Period OpensMay 19, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
273
Keywords
CDER
Citizen Petition
Antidepressant Coalition for Education
Requests that the FDA require the immediate
revision of all SSRI and SNRI antidepressant
product labels (included branded and generic
formulations) to warn of serious
and severe risks
Data from Regulations.gov