FDA Law

MAY 29, 2025

Another article about CLAT (available here ) suggests FDAs model will continually learn and improve over time. Another area for which AI models may be suited in the medical device space would be post-market data, such as Medical Device Reports, where the data submitted is in a more standardized format from manufacturer to manufacturer.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

FDA Law

OCTOBER 14, 2024

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

Clinic Patient-Centered Asthma Patients 59

GeriPal

MARCH 2, 2023

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. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

MAY 8, 2025

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 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2022

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. But I think just like patients need their own preparation, really it’s the surrogate that we often leave out of these discussions, especially early on.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

JANUARY 3, 2024

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.

Manufacturing 59

Manufacturing Education Patient-Centered Vaccination 59

GeriPal

DECEMBER 7, 2023

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. And that’s a good thing to share with an older patient or client that making decisions about your activity.

Healthcare 129

Healthcare IT Education Community 129