Vivus Qnexa Review: Lunch Time Update

Relabeling and REMS Carry Day in Avandia Vote: One-Third Vote for Removal; But Post-Marketing Control Wins

Pre-Vote Summary From Avandia Day 2

Vivus’ Qnexa Pre-meeting Comment: Avandia Votes More Favorable Than They Seem

Vivus Qnexa Review: FDA Questions Focus on Safety; Avandia Spill-Over Likely

Avandia Day One Lunch-Break Report: Advisory Committee Being Asked To Adjudicate Internal FDA Dispute

Comparative Meta-Analyses at Avandia Day One (Afternoon)

Avandia Morning Update

Avandia FDA Advisory Committee Roster: 2007 vs. 2010

Avandia Advisory Committee Focal Data Points

Avandia FDA Briefing Documents: A First Look

Advisory Committee Tracker: Packed July Schedule Will Have Sweeping Impact

Avandia Update: New Analyses Add Weight To Withdrawal Arguments Being Made By FDA Drug Safety Team

Opioid Class-Wide REMS: FDA Proposes Soft Touch to Start; Key Points for Committee Likely to Be Scope and Assessment

FDA/CMS Memorandum: More Power for Postmarket Surveillance

Luveniq FDA Advisory Committee Cancellation Puts Review in Complete Limbo; Precedents Don’t Bode Well

FDA Advisory Committees: The Toughest vs. The Easiest

Novartis Gilenia Drug Introduction Is Likely To Require Six-Hour Office Visit For New Patients

Novartis Gilenia Advisory Committee Issues at FDA: Key Question Is Not If, But When, Approval Will Occur

Avandia Update: FDA Looks for Advice on Safety Monitoring From IOM Special Committee

InterMune’s Pirfenidone: Approval Without New Study is Still Possible

FDA Advisory Committee Votes Against Approval of AZ’s Rezield

ESA Advisory Committee Likely For October; FDA Will Deal With Avandia, Opioid REMS First

AstraZeneca’s Rezield Next-Generation Synagis Does Not Convince FDA Reviewers: Company Needs Strong Favorable Review from June 2 Advisory Committee

FDA and ESAs: A Look at the Upcoming Advisory Committee