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Warning Letter Pilot Could Muddy Compliance Waters, Attorney Maintains

This article was originally published in The Gray Sheet

Executive Summary

FDA's proposed warning letter pilot program could have the unintended effect of making it harder for industry to interpret certain compliance-related "gray areas," Thomas Muldoon, a partner in the Chicago law firm of Burditt & Radzius, asserted Oct. 27 at the Regulatory Affairs Professionals Society annual meeting in Washington, D.C.

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