New FDA Chief Looks Into Device Approvals

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New FDA Chief Looks Into Device Approvals

June 18th, 2009 meg

Newly named FDA Commissioner Margaret Hamburg said she is pushing earlier safety warnings to doctors and wants to address discontent in the FDA’s medical device division.

Dr. Hamburg said she wants to take a “hard look” at the Center for Devices and Radiological Health’s decision-making and an abbreviated regulatory approval process for devices.

There has been controversy involving a series of product approvals made despite the objections of FDA scientific experts who say industry has too much influence.

Hamburg says an FDA task force is also looking at how to communicate information about potential side effects faster, while addressing corporate concerns about revealing proprietary data.

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