Icon gets FDA warning letter for two antibiotic trials

Related tags Fda warning letter Contract research organization Fda

Irish CRO Icon has received a US Food and Drug Administration (FDA) warning letter relating to two studies of an antibiotic it conducted between 2004 and 2006.

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.

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