ICON plc, (NASDAQ:ICLR) (ISIN:IE0005711209), today announced it has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding clinical study management services provided by the company to one of its clients in relation to two studies conducted between 2004 and 2006. These studies related to the development of an antibiotic for the treatment of complicated skin and skin-structure infections. The FDA letter arises from its inspections of the company’s client and selected clinical sites and follows a similar letter issued to that client.
ICON is committed to working cooperatively and expeditiously with the FDA to address the matters raised in the letter.