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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions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

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. Biological aging or physiological aging varies from individual to individual.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors. Livornese and Josephine M. Notable Dates and Timelines – New MAPP published, by Dec.

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

GeriPal

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? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management. So I can say anything I want. So 5ht2 was. I love that.

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

GeriPal

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. So it’s hard to know about individual practice when I think of geriatrics or geriatric nursing because a lot of the solutions are really broad scale public health initiatives are needed, don’t you think?