Ranbaxy Whistleblower’s New Mission: How to Detect Fraud from Afar
This article was originally published in The Gold Sheet
A decade ago, Dinesh Thakur was able to perceive data integrity issues at Ranbaxy because of his unique position in the company. Today, he’s working to help pharmaceutical companies monitor their global manufacturing networks to detect such issues wherever they might occur.
You may also be interested in...
An FDA official encourages industry to use this method to audit supply chains for data integrity – even though it can be mind-numbingly tedious.
Time waits for no lab learn Ranbaxy and new owner Daiichi Sankyo as stock sinks after FDA sanctions firm for holding stability testing samples in refrigerators until its overworked lab could get around to testing them. Lab was backdating same-day testing of 30-, 60- and 90-day samples, FDA said as it slapped Ranbaxy with application integrity letter.
The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.