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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...

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… ...

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. ...

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