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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law

These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. if additional testing is required or justification would suffice), responsible individuals, proposed timelines, and any clarifying questions for FDA.

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Texas invests $50M in psychedelic drug research to treat addiction

Medical Xpress

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. But what we observed was much more complicated."

Provider 109
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Dementia and high risk surgery: Joel Weissman and Samir Shah

GeriPal

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. You have a patient with dementia severe enough that she cannot recognize relatives.

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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

We learned this and much more, and I had a great time making engine noises singing the Woody Guthrie song “driving in my car.” . I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Additional Links: (A to Z – under driving). OT programs). Alex: Yeah.

Family 102
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Nudges for Prognosis and Comfort Care in the ICU: Kate Courtright, Scott Halpern, & Jaspal Singh

GeriPal

We did another nudging trial where the deep default was for default palliative care consultations for high risk patients, and it significantly increased individuals who were receiving palliative care. We tested two different nudges individually and then we combined them. I highly encourage you. Kate 13:59 What did we do?