FDA Conflict Of Interest Waiver On Victoza Is Textbook Example For Supporters, Foes
Executive Summary
Novo Nordisk's Victoza will get US advisory committee review June 20, and Tufts Medical Center's Marvin Konstam will serve on panel even though his institution participates in a trial for Janssen's Invokana.
You may also be interested in...
Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review
US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.
Can A Safety Study Support A Superiority Claim? Barely, FDA Advisors Say
FDA advisory committee narrowly endorses CV mortality benefit claim for Boehringer/Lilly's diabetes drug Jardiance, but some panelists question wisdom of relying on study originally designed for cardiovascular safety to support a post-marketing superiority claim.
The FDA Amendments Act-A Year On
The US Food and Drug Administration Amendments Act of 2007 came into force just over a year ago and contained important ramifications for manufacturers of medical devices and in vitro diagnostics. Neena Brizmohun reports from the annual meeting of the Regulatory Affairs Professionals Society, in Boston, on how the act is faring.