Home » ICON Receives FDA Warning Letter
ICON Receives FDA Warning Letter
December 9, 2009
Dublin contract research organization (CRO) ICON received a warning
letter from the U.S. Food and Drug Administration (FDA) related to the
management of two clinical studies conducted between 2004 and 2006.
The studies, both conducted for the same client, related to the
development of an antibiotic for complicated skin and skin-structure
infections. The letter arose from FDA inspections of the client, which
received a similar letter, and selected clinical sites.
ICON said it will work with the FDA to resolve the matters addressed in
Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials
Learn More Here