FDA imposes new rules when its experts disagree about the science behind a device

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New Rules When Scientists Disagree at FDA (Orthopedics This Week)
What happens when you go to the FDA with an application and the scientists within the agency disagree about the science behind your device or procedure?
These disagreements lie at the heart of the lawsuit by the FDA 9 whistleblowers over exposure to radiation. Internal disagreements and the ensuing public prosecution by The Wall Street Journal of Regen Biologics, Inc. and their appeals process brought down the company's application and, according to some, hastened the departure from the agency of Dan Schultz, M.D., the former Di...

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