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Understanding the FDA perspective

Paul Yock of Stanford's Biodesign and Jay Watkins of De Novo Ventures led a discussion with Marie Johnson, Darin Buxbaum, Brian Fahey and Peggy McLaughlin on the topic of clinical and regulatory strategy at a recent Life Science Ventures Summit hosted by the Kauffman Foundation (0:25:21-0:33:52).

on December 12, 2013
Category:  Execution  Creation 
Give your medical device a proper FDA submission with these 3 keys

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."

on September 25, 2013
Category:  Execution  Creation 
5 tips for startups seeking regulatory approval

There are benefits for startup medical deviceand drug development companies to court regulators like the U.S. Food and Drug Administration early to ensure strong communication on what's expected and what a comany's product(s) can deliver. But on the other hand,there can be some unforeseen challenges as well. And of course the FDA has been known to change its mind and request more and more data.

on August 12, 2013
Category:  Creation 
The FDA’s med tech priorities – and what they mean for entrepreneurs

At the MedTech Investing Conference in Minneapolis on Wednesday, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health outlined the administration's key priorities related to the med tech industry.

on May 10, 2013
Category:  Execution 
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