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US FDA’s Role In Artificial Intelligence/Machine Learning Development Is ‘Convener,’ Califf Says

 
• By Derrick Gingery

Speaking at the Consumer Electronics Show, FDA commissioner says agency and industry must work together to understand AI/ML and continuously assess the algorithms for efficacy.

Artificial intelligence
Califf said AI algorithm assessment needs to be continuous. • Source: Shutterstock

Robert Califf sees the US Food and Drug Administration learning about artificial intelligence along with industry and expects the agency will need outside help regulating the systems.

Hundreds of products using AI have been approved by the agency. But they have so-called closed algorithms, which cannot change over time

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Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

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

 
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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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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.