Remove Chronic Disease Remove Consulting Remove Events Remove Relationship
article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Lastly, the reforms enacted by FDORA required that FDA publish guidance on early consultation with FDA to identify novel surrogate or intermediate clinical endpoints, use of novel trials designs for postapproval studies, the expedited withdrawal procedures, and considerations related to the use of surrogate and intermediate clinical endpoints.

Clinic 64
article thumbnail

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.”

article thumbnail

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. So if you already have a condition, you might be able to prevent events. The time it takes to look at chronic disease prevention or outcomes is just, it’s in the word chronic.

IT 116