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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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ACI’s 43rd FDA Boot Camp – New York City Edition

FDA Law

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. As such, we can offer our readers a special 10% discount. You can access the conference brochure and sign up for the event here. And it is exactly that! The discount code is: D10-999-FDA25.

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications.