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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinic 64
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Not “burnout,” not moral injury—human rights violations

Pamela Wible MD

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. So why are physicians experiencing physical and mental collapse from overwork?

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Episode 322: Antiracism in Medicine – Episode 24 – Leveraging Narrative Medicine to Cultivate Antiracist Praxis

The Clinical Problem Solvers

Episode Learning Objectives After listening to this episode, learners will be able to: Illustrate the relationship between narrative medicine and healing relationships. What the term gestures towards is the centering of the ‘story’ in healing relationships. The show notes for this episode were written by Sudarshan Krishnamurthy.

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Episode 309 – Antiracism in Medicine Series – Episode 23 – Anti-Blackness, Anti-Fatness, and Food Shaming

The Clinical Problem Solvers

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. All of this contributes to various mental health challenges that are consistent with surveillance in not only a wider police-state but also the patient-physician relationship. Physical Fitness.”

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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Or somebody who has other physical cognitive problems at any age. Because how that is approached can have lasting effects on relationships, unfortunately. I’m going to first turn to Emmy.

IT 102
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RCT of Chaplaincy: Lexy Torke, Karen Steinhauser, LaVera Crawley

GeriPal

Lexy: Yeah, so I can say that I became about, in 2014, I had the opportunity to lead a center at our health system called the Evans Center that focuses on religion, spirituality, and health. Lexy: The domains were meaning and purpose, relationships, transcendence and peace, and self-worth and identity, and we developed those.

IT 99
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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast.