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CLIAC

This article was originally published in The Gray Sheet

Executive Summary

Proposals for a new CLIA waiver workgroup to devise procedures for rescinding CLIA waivers are unnecessary FDA requirements regarding labeling already provide sufficient safeguards for CLIA-waived products, AdvaMed reps maintain following Sept. 17 CLIAC meeting comments on the topic (1"The Gray Sheet" Sept. 22, 2003, p. 16). At the meeting, CLIAC decided to establish the waiver workgroup to flesh out CLIA waiver policy. AdvaMed will be represented in the workgroup by CLIAC industry rep Luann Ochs, Roche Diagnostics...

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