ICON Receives Warning Letter Relating to Two Studies
ICON plc
Niamh Murphy, Corporate CommunicationsNiamh Murphy, Corporate Communications
Tel: +
353 –1-291-2180
Tel: +
353 –1-291-2180
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.
About ICON plc
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
ICON/ICLR-F
