According to Janet Trunzo, executive vice president of regulatory affairs at AdvaMed, the end of negotiations for the next version of MDUFMA is near. Speaking at the annual meeting of the American Institute for Medical and Biological Engineering this morning, Trunzo told attendees to expect a press release about the proposal within days. The negotiations involving the user fee system have been between AdvaMed, FDA, and key members of Congress. MDUFMA must be reauthorized by the end of September, and there's been a lot of closed door discussion about how it should be restructured, along with whether any of the other provisions should be changed. Stay tuned for more information about the proposed agreement.
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