Antidepressant “Black Box” Decision Imminent, FDA Tells Congress
Executive Summary
FDA will reach an internal decision on whether to request a "black box" warning on pediatric suicidality for all antidepressant labeling as early as the week of Sept. 27
You may also be interested in...
As Medication Guide Requirements Increase, FDA Considers Electronic Delivery
FDA is considering electronic distribution of Medication Guides as their use increases and questions are raised about whether they are consistently reaching patients
As Medication Guide Requirements Increase, FDA Considers Electronic Delivery
FDA is considering electronic distribution of Medication Guides as their use increases and questions are raised about whether they are consistently reaching patients
Antidepressant Fallout Includes Change In FDA Pediatric Study Procedure
Studies conducted under the Best Pharmaceuticals for Children Act will be included in labeling, FDA Office of Medical Policy Director Robert Temple, MD, told the House Energy & Commerce/Oversight Subcommittee Sept. 23