List of Contributions

Facet Technologies, a worldwide manufacturer (mostly OEM) of blood sampling products primarily for the diabetes care market, is recruiting for a Regulatory Affairs Specialist position.  This is a new position prompted by regulatory challenges in both the US and the EU.  Working familiarity with US and ...

Hi Yasser, This generally refers to a FDA requirement in a PMA that the sponsor conducts a post-market clinical study to gather additional clinical data regarding the device. As most pivotal clinical studies to support approval have inclusion/exclusion criteria that are geared to provide favorable data ...

My advice is have the legal department offer the response to the FDA.  The Clinical Study Group, even if closing the sites, should author a closure report.  I really don't see a way out of having some sort of closure to the study.  Your legal counsel may be correct in that there is no law that requires ...