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FDA's Approach to AI in Medical Products

FDA's Approach to AI in Medical Products
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FDA Charts Course for Regulating AI Used in Medical Products | McDermott Will & Emery

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER,. ....

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IQVIA: As use of AI, ML and NLP increases - compliance must keep up

Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear. ....

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IQVIA: As use of AI, ML and NLP increases - compliance must keep up

Always the buzz theme at pharma conferences, the subject of artificial intelligence (AI) continues to crop up more and more frequently. Naturally with more and more people using it for work, new regulations on data use and management are starting to appear. ....

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FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices

FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices
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