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May 5, 2024
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.
April 29, 2024
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.
November 6, 2023
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.
May 11, 2023
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for...
May 10, 2023
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
April 4, 2023
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the โDHTโฆ
January 11, 2023
The UK's medical device digital health sector continues to show signs of steady growth and is set for further transformation and development in 2023.
December 20, 2022
In October 2022, the White House Office of Science and Technology Policy (OSTP) published a Blueprint for an AI Bill of Rights (โBlueprintโ), which shared a
November 21, 2022
On September 29, 2022, the United States Government Accountability Office (โGAOโ) and the National Academy of Medicine (โNAMโ) jointly published a detailed Report to Congressional...
May 23, 2022
In recent years, 3D pathology imaging has developed to achieve precision diagnosis. Using AI/ML to reduce the cognitive demands on clinicians and/or...