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.