FDA could be source of innovation, Hamburg says - Denver Business Journal

Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

"The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

“We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

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Recommendations of FDASIA Health IT Workgroup Accepted - FDA Law Blog

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FDA Law Blog: Recommendations of FDASIA Health IT Workgroup Accepted:

"The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to "post a report - within 18 months (or by January 2014) - that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."  FDASIA Section 618."

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