Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud?

 
• By Derrick Gingery

The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.

Computer hard drive and stethoscope
Sponsors are expected to police their supply chains, but their authorities do not match those of FDA inspectors. • Source: Alamy

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