Opioid REMS Development Achieves Milestone: Another Public Meeting
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA will meet with manufacturers on Dec. 4 to discuss progress on developing the safety program.
You may also be interested in...
Reopening Of Public Comment Period For Opioid Class REMS Confirms Long Road Ahead
FDA is reopening the public comment period for the class-wide opioid Risk Evaluation and Mitigation Strategy until Oct. 19, 2010.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
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.