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GMP Warning Letters With Unusual Language Are Red Flags, Attorney Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Companies should pay attention to non-boilerplate language inserted at the end of a warning letter, which could signal FDA's intent to pursue more serious enforcement action, Sidley Austin's Bonner says during Drug & Device Dialogue audio conference. A "quiet period" in communications with FDA can precede a seizure, he warns.

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