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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. Moreover, it was also interesting to see how FDA discussed the concept of unmet medical need in the limited fashion that it did in this new guidance.

Clinic 64
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How to manage GLP-1s in the hospital

Today's Hospitalist

Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. These medications are truly life-changing for many patients.” Nor should they be.

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

GeriPal

Summary Transcript CME Summary When treating heart failure, how do we distinguish between the expanding list of medications recommended for “Guideline Directed Medical Therapy” (GDMT) and what might be considered runaway polypharmacy? He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge.

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

FDA Law

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. Alex 00:20 We are delighted to welcome Anna Pleet, who did her medical training in Italy and is now doing internal medicine residency in the United States. Anna 07:06 Thank you.

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

GeriPal

All of them offer the same array of services, really emphasizing social determinants of health and preventive services like falls prevention, chronic disease, self-management, caregiver training. I knew them, I developed a relationship with them. It’s somebody different every month, and you never develop that relationship.