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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

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.

Califf said “90-plus percent” of the inspectorate’s work “is either manufacturing or traditional clinical trials,” which he said, “goes extremely...

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EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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