ICON receives FDA warning letter

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.

Source:

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

Sign in to keep reading

We're committed to providing free access to quality science. By registering and providing insight into your preferences you're joining a community of over 1m science interested individuals and help us to provide you with insightful content whilst keeping our service free.

or

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
How ‘free from’ and ‘organic’ claims dominate baby food marketing in NZ