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A Chihuahua or a Muffin? FDA Announces Plans for Aggressive Use of Artificial Intelligence

FDA Law

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. Another article about CLAT (available here ) suggests FDAs model will continually learn and improve over time. By Adrienne R.

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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law

California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J. 21 U.S.C. §

Clinic 59
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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. It’s not a controlled substance medication. J Am Geriatr Soc. Tasce: Yes.

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

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Gordon Alwasa.

Illness 106
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Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

Start by reading this article by Sean Morrison, Diane Meier, and Bob Arnold in JAMA , and this response from Rebecca Sudore, Susan Hickman, and Anne Walling. And I don’t think necessarily, that appointment needs to be a medicalized process. If you’re new to this discussion, don’t start with this podcast!

Illness 72
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Animals Need Drugs Too, But Not Without CVM Approval

FDA Law

Enter the FDA’s Center for Veterinary Medicine (“CVM”). To carry out its mission, CVM has the same enforcement tools that the rest of FDA, like CDER and CDRH, have, including the authority to conduct inspections, issue warning letters, seize products, add manufacturers to import alerts, and impose penalties on bad actors.

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

GeriPal

Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. I mean, many people in their mid to older years are on certain medications. I look forward to our conversation.