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

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.”

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

The planned reorganization of the US Food and Drug Administration’s Office of Regulatory Affairs will include a program to train an inspection team to evaluate real-world evidence in the hopes of encouraging drug developers to use it, Commissioner Robert Califf said during an 11 September Friends of Cancer Research meeting.

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