Full Press Release Details
Receives Warning Letter Relating to Two Studies
DUBLIN--(BUSINESS WIRE)--December 4, 2009--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.
ICON plc is a global provider of outsourced development services to the
pharmaceutical, biotechnology and medical device industries. The Company
specialises in the strategic development, management and analysis of
programs that support clinical development - from compound selection to
Phase I-IV clinical studies. ICON currently has about 7,000 employees,
operating from 68 locations in 38 countries.
Further information is available at www.iconplc.com
Niamh Murphy, Corporate Communications