The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...
On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas to industry members ...
In addition, the FDA has partnered with the Food Safety Preventive Controls Alliance (FSPCA) to develop training for the food industry on the Food Traceability Rule. Curriculum development has been ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Joseph Shea, who sells athletic wear in Myrtle Beach, South Carolina, wonders and worries about the food he eats. The chemical ingredients with mystifying names. The references on product labels to ...
Wednesday's House hearing on restoring trust in the FDA included something that doesn't happen often: testimony from an industry representative begging for his industry to be regulated. "Lack of ...
Please provide your email address to receive an email when new articles are posted on . 3D Systems announced FDA clearance of its total ankle patient-matched guides for use with the total ankle ...
This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. WASHINGTON (AP) — Dr. Vinay Prasad, a ...
Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and ...
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