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Inspection Overhaul Is Early Test Of US FDA’s ‘Digital Transformation’

 
• By Michael McCaughan

US FDA’s reorganization of its inspection office will also showcase efforts to enhance the agency’s IT infrastructure. But Commissioner Califf is warning the agency’s ‘digital transformation’ efforts could still fall victim to internal silos and external pressures to ‘divide and conquer.’

digital transformation
WHAT LIES ON THE OTHER SIDE OF THE DIGITAL TRANSFORMATION FOR FDA? • Source: Shutterstock

The US Food & Drug Administration’s reorganization of its inspectional functions will also be a testing ground for the agency’s “Digital Transformation” efforts.

FDA unveiled its reorganization plan for the Office of Regulatory Affairs, which will be renamed the Office of Inspections & Investigations, on 13 December

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