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FDA’s CDER Is Fostering Use Of Artificial Intelligence In Drug Development

 
• By Brenda Sandburg

Center for Drug Evaluation and Research plans to issue a request for information this year to engage stakeholders on issues related to AI and machine learning. It received 175 AI/ML submissions in 2022, up from 14 in 2020.

AI medical
FDA is focusing on use of artificial intelligence and machine learning to enhance drug development • Source: Shutterstock

The US Food and Drug Administration’s involvement in artificial intelligence and machine learning is well known on the device side. But the Center for Drug Evaluation and Research has been working under the radar to facilitate use of the technologies in drug development.

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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

 
• By Neena Brizmohun

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

 
• By Michael McCaughan

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.

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

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

 
• By Neena Brizmohun

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.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
• By Eliza Slawther

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.