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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Eric 11:57 In, let’s say, my clinic. How do you think about this?

IT 120
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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

IT 102
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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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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

Illness 107
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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.