Icon gets FDA warning over antibiotic studies

AP News
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Posted: Dec 04, 2009 11:29 AM

Clinical research company Icon PLC said Friday it received a warning from the Food and Drug Administration about its management of two studies between 2004 and 2006.

Icon provides outsourced development services to drug and medical device makers. The company said the FDA warning concerns the management work Icon did on trials of an antibiotic drug intended to treat complicated skin infections. The warning is based on inspections of the client and some clinical sites that were involved in the research.

The Irish company said the client _ which was not named _ received a similar message from the FDA. Icon did not detail the services the FDA is citing or the drug that was being researched. Icon said it is committed to working with the agency and addressing the problems.

In morning trading, Icon shares fell $1.15, or 5.1 percent, to $21.53.