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Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
In a mammogram, fatty tissue shows up as black on the image, while fibroglandular tissue lights up as white. Cancer also ...
July announcement, the FDA revealed plans to revoke 52 outdated food standards, calling them “obsolete.” These rules have ...
Explore the FDA’s 2025 Human Foods Program Guidance Agenda and what it means for US food and beverage businesses. Key ...
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...
The FDA’s new draft guidance comes on the heels of a reflection paper from the European Medicines Agency on the use of AI in the drug product lifecycle, finalized in September 2024.