The anticipation of a Republican-controlled government with Donald Trump serving a second term as president has left some women fearful over access to reproductive healthcare. On the day after Trump's ...
Michael and Kendra Haken watch a city crew on the Pope-Chaucer Bridge clear debris from San Francisquito Creek around 11 a.m. on Jan. 9, 2023. Photo by Magali Gauthier. A new plan to bolster flood ...
Millions of Americans could soon have access over-the-counter contraception without any out-of-pocket costs. Women without one currently pay as much as $50 for one box of Plan B. "The proposed rule we ...
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement ...
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence ...
At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission ...
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