Tag Archives: FDA

Jenny Regan

Innovation at the FDA – Cultural Changes

05.17.2012 by Jenny Regan

A few weeks ago I had the pleasure of moderating the Q&A session for a Women in Bio event in DC. This installment featured Dr. Jeffrey Shuren, Director of FDA’s CDRH, which is responsible for reviewing and approving medical devices for use and sale in the US.

Conrad Laskowski

The Need for Approval

05.04.2011 by Conrad Laskowski

What do cosmetics, bio-pharmaceuticals, and medical devices all have in common? The Onion News reports that a shining new age of industry leaders are standing up, drying their eyes, not eating their vegetables, and adopting a staunch “FDA who?” mentality…

Chad Schneider

Medical Device Interoperability

07.27.2010 by Chad Schneider

Is it possible to verify and validate the safety and efficacy of medical devices if they could be connected to unknown current and future products? The medical device industry is working with the FDA to work out the safety issues of device interoperability.