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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

FDAs Overview of When Accelerated Approval is Appropriate The new draft guidance explains, that there are two circumstances in which the accelerated approval authority would most clearly apply: (1) when the course of the disease is long or (2) the clinical event that is relevant for demonstrating benefit occurs infrequently.

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How to manage GLP-1s in the hospital

Today's Hospitalist

“You want someone who can monitor patients’ side effects and have a longitudinal relationship with them.” Laudenslager, is a chronic metabolic disease with highly complex pathophysiology—”and we are programmed to regain the weight we lose with lifestyle measures.”

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Guidelines or Goals in Heart Failure: A Podcast with Parag Goyal, Nicole Superville, and Matthew Shuster

GeriPal

We’ve also invited two amazing cardiologists, Parag Goyal and Nicole Superville, to join us about GDMT in heart failure with reduced ejection fraction (HFrEF) and in Heart Failure with preserved EF (HFpEF). He’s in Boston. He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge. Parag 01:06 Thank you.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog

The Strategy must address appropriately restructuring the Federal Governments response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease.

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Optimizing Nutrition in Aging: A Podcast with Anna Pleet, Elizabeth Eckstrom, and Emily Johnston

GeriPal

Widera and Smith have no relationships to disclose. Guests Anna Pleet, Elizabeth Eckstrom, and Emily Johnston have no relationships to disclose. Summary Transcript Summary What is a healthy diet and how much does it really matter that we try to eat one as we age? ABIM MOC credit will be offered to subscribers in November, 2024.

IT 116
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How State and Local Agencies on Aging Help Older Adults: Susan DeMarois, Greg Olsen, and Lindsey Yourman

GeriPal

Summary Transcript Summary You may have heard of Area Agencies on Aging, but do you really know what they do or how they do it? What about State Departments of Aging or state master plans for aging? Do you know how these agencies fit in with programs like Meals-on-Wheels or other nutritional support programs? Susan: It is my anthem.