Avandia Reviewers Weigh In
Executive Summary
After bringing the fate of rosiglitazone’s REMS to its advisory committee, FDA let the reviewers who presented vote on the same question.
You may also be interested in...
FDA Polled Review Staff On Avandia REMS Changes
Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
Biocon Biologics Refreshes Management
Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.
Optibac Launches Natural Children’s Probiotic Immunity Supplement In Sustainable Pack
The UK's Optibac responds to sustainability and naturals trends with an all-in-one immunity and gut health food supplement especially designed for children.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: