US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence, Califf Says

 
• By Kate Rawson

The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”

health data
RWE training for FDA inspectors should help encourage sponsors to use the data, FDA Commissioner Robert Califf said. • Source: Shutterstock

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