The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Penn State Extension will offer a course to help produce growers meet food safety rules as outlined in the Food Safety Modernization Act, also known as FSMA, administered by the ...

Ozempic, the drug that was originally approved to treat type 2 diabetes, has now also been approved by the FDA to reduce ...

JAKARTA: The National Nutrition Agency (BGN) and the Food and Drug Monitoring Agency (BPOM) have agreed to join forces to ...

Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making ...