Medical device makers have expressed doubts about the US Food and
Drug Administration’s (FDA) desire to increase user fees to help improve
the device review process, but talks on the fees between industry and
the agency continue with the hope of reaching an agreement. "I'm not a
big believer that you throw money or people at a problem; you address
the problem," James Mazzo, senior vice president of Abbott Medical
Optics and chairman of the Advanced Medical Technology Association
(AdvaMed) said earlier this week. In remarks a few days later at
AdvaMed’s conference, Jeffrey Shuren, director of FDA’s Center for
Devices and Radiological Health admitted fault on FDA’s part but
continued to argue his case for more resources. AdvaMed president
Stephen Ubl reported that both sides were "making progress" on reaching a
user fee agreement.
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