Certain work at Purdue involves sensitive information, equipment, or technology that is subject to U.S. export control regulations or national security-related contractual requirements. Sharing ...
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 ...
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 ...
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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