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AI Complexity Not A ‘Free Pass’ To Dodge Regulatory Standards, EMA Warns

 
• By Eliza Slawther

Companies that use AI technologies will be responsible for demonstrating that regulatory standards are met and that the data they provide “has not been synthetically generated or completely made up,” an EU workshop heard this week.

EMA
• Source: Shutterstock: Alessandro Zappalorto

Artificial intelligence has many clinical and non-clinical use cases within the drug development lifecycle, but mitigating risks will require a culture where individuals “are not afraid to say that they are wrong,” says a senior EU regulator.

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AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

US FDA Under Makary: MAHA With A Lighter Touch

 
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Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers

 
• By Brian Bossetta and Elizabeth Orr

The exact number of layoffs at the FDA as part of the Trump Administration’s pledge to shrink the federal government is unclear, but the most came from the agency’s Center for Devices and Radiological Health.

More from Advanced Technologies

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
• By Bridget Silverman

New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.