The New Zelnorm-al: US FDA’s Do-Over On Cardiovascular Safety
Zelnorm’s revival is self-conscious effort to revisit a decision made in “Safety First” era a decade ago. Is dropping CV outcomes standard for diabetes drugs next?
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Tearing Down The Goalposts (Part 2): Diabetes Debate Has Toned Down At US FDA
An October US FDA advisory committee meeting to discuss type 2 diabetes drug cardiovascular safety standards replayed a July 2008 meeting, but in a more harmonious key. That reflects the changing climate for FDA – but also a change in who was invited to participate.
The New Zelnorm-al (Part 2): More Thoughts On The Revival Of The 5HT4 Class
Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.
US FDA Panel Will Reckon With Need For Diabetes Drug CV Risk Assessments
Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.