Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Janssen’s Esketamine Needs Better Defined REMS, US FDA Panel Says
Advisory committee overwhelmingly endorses approval for patients with treatment-resistant depression but says proposed Risk Evaluation and Mitigation Strategy needs refinement, including clarifying the types of facilities where the drug will be administered.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.