The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.
In a tight vote Tuesday, a U.S. Food and Drug Administration Circulatory Systems Device Advisory Panel recommended Medtronic‘s (MDT) CRT devices are beneficial for biventricular pacing when treating patients with atrioventricular block and left ventricular systolic dysfunction. The vote that the overall benefits outweigh potential risks–four recommend, three no and one abstain–was based on clinical […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
It’s stressful. If you’re a startup, your company depends on it: it’s your FDA panel meeting. And, as Michael C. Morton, the vice president of global regulatory affairs at Medtronic (MDT), said, “It’s kinda culminated with throwing the dice.” In the “How to Avoid Making a Bad Submission to the FDA…” panel at Advamed 2013 […]