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EMA, US FDA Worry About AI’s Pitfalls And Promises

 
• By Derrick Gingery

The “garbage in, garbage out” issue remains top of mind as AI models continue to be integrated into drug development. The FDA still has a lot of learning to do, Jacqueline Corrigan-Curay says.

AI and human hand
Could AI exacerbate clinical trial diversity concerns? • Source: Shutterstock

US and European officials have big plans for artificial intelligence, including use in application review and safety signal identification, but both regulators remain concerned about the software’s limitations.

AI could help sponsors identify potential new drug targets or analyze the increasing volume of drug safety reports received each...

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AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

More from Advanced Technologies

Vinay Prasad Out At US FDA

 
• By Sarah Karlin-Smith

The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.