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Drop in FDA Warning Letters Signals Enforcement Shift

blogs.wsj.com

The drug industry has been grumbling over how tough on safety the FDA is these days, but by one measure the agency has fallen off significantly a few years ago. The number of warning letters the FDA sends out has been cut in half in recent years, FDA is mailing fewer of these to regulated companies

In fiscal 2001, the FDA sent out 1,032 of the letters. That fell to 538 in 2006 and 471 in 2007. The decline followed a policy shift in 2002, when the agency started sending all warning letters through its office of chief counsel. As Dow Jones reports, the letters can be over anything from “the mislabeling of chocolate chip cookies to the improper manufacturing of blood bags.”

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