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Drop in FDA warning letters points to shift in enforcement.(FDA management)(United States. Food and Drug Administration)
- Article from:
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Adverse Event Reporting News
- Article date:
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June 17, 2008
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FDA warning letters to industry dropped by half in the last 10 years, according to a June 6 report in "The Wall Street Journal."
In 2002, FDA changed its policies and required that all warning letters go through FDA's chief counsel office, a move designed to strengthen the letters and make them legally consistent and credible.
In fiscal year 2001, the year before this change took effect, the agency issued 1,032 warning letters. In 2006, FDA sent 538 letters, and in 2007 it sent 471, FDA data show.
Some members of Congress, FDA staffers and former FDA officials have criticized the change, suggesting it favored industry. Since taking control of Congress in 2007, ...