US FDA’s Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

The FDA flags concerns about data integrity issues at CROs. • Source: Shutterstock

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