Icon gets FDA warning letter for two antibiotic trials
While more details have yet to be made available, a press statement issued by the contract research organisation (CRO) confirmed receipt of the letter.
The firm said that the letter covers management services it provided to a client during the clinical development of an antibiotic for the treatment of complicated skin and skin-structure infections and added that the warning arises from US Food and Drug Administration (FDA) inspections of selected clinical sites.
Company spokesperson Niamh Murphy told Outsourcing-pharma that: "Due to client confidentiality and as a policy, Icon does not comment on the specific details of studies we carry out on behalf of our sponsors." She added that the firm is committed to working with the FDA to address matters raised in the letter.
