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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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

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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Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

FDA Law Blog

HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. She also specializes in medical device software and digital health. Hyman, Phelps & McNamara, P.C. Ellison, Managing Director at HPM.

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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So medication adjustments.

Illness 107
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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. And then for medical education, I know they are doing a lot as well.