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).
Members of the panel agreed that dealing with the FDA is a complex process, but they had suggestions on what entrepreneurs can do to help themselves through the process:
"I went to the FDA website and I did a lot of competitive due diligence, looking at the other companies in my space," said Buxbaum.
"It's a process in flux," said McLaughlin. "That's one of the areas they're trying to change, improve, fix...You can be a leader and help them do it better, by helping them along the way...They want to understand your story, so you want to help them by making your story very understandable ... Try and well understand the rules and understand the arcane aspects of it so you can give them what they need."
"The easiest place to start is by looking at your predicates or similar devices in the marketplace and seeing how good of a fit it is or is not going to the FDA website," said Fahey. "Go find a consultant...We did all of our own regulatory analysis in-house and then we handed almost-finished documents to a regulatory consultant."
Weekly Wisdom from Kauffman is a regular feature on eMed highlighting helpful advice from the Kauffman Foundation.