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OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.
OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.
US, UK, and Canada released a document identifying principles that draw upon a 2021 guidance on best practices for AI/machine learning-enabled medical devices.
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for...
FDA expects manufacturers to commit to transparency and real-world performance monitoring, to periodically update FDA on changes implemented as part of the approved pre-specifications and algorithm change protocol and follow Good Machine Learning Practice guiding principles