Over the past few months, I’ve had numerous conversations with US Manufacturers, Regulators and others about CFDA’s Innovative Device Pathway. And it’s clear there’s a real misunderstanding about the actual benefits and challenges this Pathway brings. In this article, I try to make it a little clearer on what leads to a successful application and […]
Innovative Pathways for fast track approval of new technologies are continually in the news. These pathways attempt to serve industry development goals in the guise of meeting unmet clinical needs. Still it’s a laudable goal. But are these programmes effective? or safe?