GMP Warning Letters With Unusual Language Are Red Flags, Attorney Says
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
GlaxoSmithKline's February recall involving the two drugs did not encompass all affected lots, FDA says in announcing seizure of all doses and lots of the products. The action follows two "Form 483" reports in the last two years for GSK's Cidra, Puerto Rico facility, where the antidepressant and antidiabetic drugs are manufactured.
The company and its vaccine distributors will determine whether contracts for 2004 will be extended for the next flu season given uncertainty over whether Fluvirin will be available. Additional clarity on Fluvirin supply is expected in “early spring.”
Dr. Reddy's, GSK, Ranbaxy and UCB among manufacturers that could see prices reduced under government order that reflects issues raised in Gleevec patent dispute.