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OIVD In Brief

This article was originally published in The Gray Sheet

Executive Summary

New fees to compensate OIVD for CDER consults? Director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) floats the idea of sharing user fees or pursuing some other cost-sharing initiative with FDA's Center for Drug Evaluation and Research (CDER) to compensate for the expanding amount of personalized medicine-related product consults CDER is sending its way. "We are getting an increasing number of consults from CDER because of personalized medicine, which is taking an increasing amount of workload, and we get nothing from them," OIVD Director Alberto Gutierrez said at an April 22 roundtable discussion at the Association of Medical Diagnostics Manufacturers annual meeting in Bethesda, Md. "We would like some user fees or to find a way for CDER to share the wealth with us," Gutierrez said in response to a question regarding any user fee reauthorizations OIVD might be seeking. Such an arrangement could be a challenge, however, since user fee laws differ for FDA's device and drug centers and are negotiated independently

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