All regulations
Nonrulemaking
FDA
FDA-2018-P-1846
Requests that the FDA immediately require the addition of boxed warnings, warning, preacautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor products, including branded and generic formulations to warn of serious and severe risks.
Documents
62
Comments
35
Key Dates
Comment Period OpensMay 11, 2018
Comment Period ClosesNov 8, 2018
Documents
| Type | Title | Status |
|---|---|---|
Other |
Comment Statistics
Total Comments
35
Keywords
Citizen Petition
CDER
Data Based Medicine Americas Ltd.
immediately require the addition of boxed
warnings, warning, preacautions, and highlights
of prescribing information to the product
label for all selective serotonin reuptake
inhibitor and serotonin-norepinephrine
Data from Regulations.gov