FDA Law

MAY 29, 2025

Another article about CLAT (available here ) suggests FDAs model will continually learn and improve over time. Therefore, it seems reasonable that AI models could be trained on the data, provide useful insights to reviewers, and speed up review times. We have all seen AI failures online, some amusing (e.g.,

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

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

FDA Law

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). Responsible for “Protecting Human and Animal Health,” CVM makes sure that the drugs, devices, and food we provide for our pets are safe and effective. So, much like humans, pets are living longer and facing the ailments so common to old age.

Manufacturing 59

Manufacturing Education Patient-Centered Vaccination 59

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. And I would say too, as a primary care provider, it really doesn’t take that long to ask people about a surrogate decision maker. Welcome to the GeriPal podcast Susan.

Illness 72

Illness IT Healthcare Patient-Centered 72

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. What do we do to very concretely provide heat shelters and cool shelters? I look forward to our conversation.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Court of Appeals (again, see our post ).

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Manufacturing Supply Chain Patient-Centered Utilities 98