Data integrity focus of FDA warning letter
This article was originally published in The Gold Sheet
Executive Summary
An Oct. 23 warning letter cited Sanofi-Aventis for failing to take action against a clinical investigator who had falsified case report forms and documentation to support the existence of a fictitious subject. FDA alleges that Aventis failed to secure compliance of the investigator, terminate the investigator or stop shipping the drug, Ketek, an antibiotic, and notify the agency after discovering violations, as required by FDA. The letter is another signal that FDA investigators are continuing to focus attention on data integrity issues