Opioid REMS Development Achieves Milestone: Another Public Meeting
This article was originally published in The Pink Sheet Daily
FDA will meet with manufacturers on Dec. 4 to discuss progress on developing the safety program.
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FDA is reopening the public comment period for the class-wide opioid Risk Evaluation and Mitigation Strategy until Oct. 19, 2010.
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One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.