CDRH is unlikely to receive $15 mil. in additional funds in FY 2003 for user fees, making the task of obtaining the $45 mil. necessary to sustain the fledgling program beyond 2005 all the more difficult
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The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
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Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
