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FDA Responds to Device Industry Study BY LAUREN UZDIENSKI, NOVEMBER 30, 2010

FDA News reported (subscription required) comments from agency spokesman Dick Thompson in response to a device industry survey published last week. The study, partially funded by the MDMA, concluded that the agency's process is slow, costly and unpredictable compared to the EU's.

Thompson noted "significant flaws" in the survey, including that a low response rate (about 20%) may have biased the results. Additionally, he said comparing the FDA's process to the EU's is "apples to oranges" because companies engage with the FDA earlier in the development process than they do in the EU.

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