Selling Sentinel: FDA Highlights Vision For Broader Role For Data Network At Brookings

19 Aug 2013

• By Jacqueline Fitton and Michael McCaughan

FDA’s Janet Woodcock used her time at a conference on biomedical innovation to highlight ways to use FDA’s Sentinel network more broadly to standardize, and hopefully streamline comparative effectiveness research.

The Food & Drug Administration’s role in biomedical innovation has, historically at least, been defined in pretty narrow terms: FDA is the gatekeeper. Until a new technology meets FDA’s standards for safety and efficacy, it can’t be marketed.

That is a powerful and important role, to be sure. But, fundamentally, a negative one: FDA’s job is to say...