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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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. 2014 Feb;103:126-133. New York City. link] Metzl JM, Hansen H.

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

The Clinical Problem Solvers

As an editor, movement media and narrative strategist, and storyteller, Harrison uses their extensive history as a community organizer—which began in 2014 during their first year at Morehouse College—to frame their political thought and cultural criticism. Physical Fitness.” Journal of Women’s History, 29(2), 14–37. Time Magazine.

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

GeriPal

Or somebody who has other physical cognitive problems at any age. Because how that is approached can have lasting effects on relationships, unfortunately. This is something we’ve heard from people: that if you just bring it up every year as part of your routine physical, like, “Any concerns about driving?”

IT 102
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PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

By the time he got into us, the tumor grew, he had experienced, he was experiencing significant pain and so trauma, informed care and building a relationship with him was such a big part of the care. Naheed 15:56 2014. Eric 15:57 2014. I’m guessing, like here, especially in 2014, almost none of it was. Yeah, yeah.

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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