Executive Briefing Series (formerly The Food & Drug Letter)

The FDA Center for Drug Evaluation and Research issued 108 drug-related warning letters in fiscal year 2011. That’s down from 171 warning letters in fiscal 2010. Similarly, the Center for Biologics Evaluation and Research issued eight warning letters in fiscal 2011, down from 15 in 2010. The FDA’s production of warning letters has shifted away from drug manufacturers toward food and tobacco companies, and this shift is showing up in raw numbers.