News - National
FDA warns Pfizer for lax oversight of drug study
Posted: Apr 20, 2010 11:20 AM by Bea Karnes, News First 5
Updated: Apr 20, 2010 11:20 AM
Federal regulators say the drugmaker Pfizer has failed to correct problems with its testing procedures that resulted in overdoses for more than two dozen patients during a company trial.
The Food and Drug Administration has issued a warning letter saying Pfizer is not properly monitoring physicians testing an experimental medication, which the agency did not name.
The FDA warning follows up on problems first cited in 2006, when 26 patients in a company trial received overdoses of the experimental drug. Despite Pfizer retraining the physicians, FDA says three additional overdoses occurred in 2007.
A July 2009 inspection, which prompted the new warning found Pfizer was still not following its own guidelines for safely conducting the study.
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