In addition to evaluating the safety of software as a medical device (SaMD), the agency needs to devote more resources to evaluating its efficacy and ...
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In 2012, a deadly outbreak of meningitis swept across a college campus in the Northeast, leaving students terrified and public health officials ...
Announcement marks a pivotal shift in emphasis to modernize drug testing everywhere and reduce animal suffering WASHINGTON (April 11, 2025)—Humane World ...
FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions ...
During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine ...
