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Friday, December 11, 2009

ICON Warning Letter from the FDA

Please check out a recent warning letter sent to ICON Clinical Research in regards to monitoring services they provided for two antibiotic trials.  My understanding is that the sponsor submitted the NDA, triggering routine inspections, and the CRO has now been asked to respond to a series of serious findings.  There were reportedly issues in regards to storage/dispensing of investigational product, protocol deviations, incomplete source documents, inadherence to the monitoring plan, and insufficiency in monitoring oversight.  It is a very detailed letter and appears to question whether 100% Source Data Verification was completed properly with a series of concrete examples of discrepancies.  As monitors, we need to comply with all regulations and stay abreast of these kinds of relevant FDA findings - hope you will find reading the warning letter as helpful as I have.  Here is the link again: 

1 comment:

Anonymous said...

Thanks for posting this. It seems really familiar; like one sent to a pharma last year.

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