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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. More specifically, the prohibition includes when a “third party (e.g.,

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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. Is there any relationship between frailty and urinary incontinence? I don’t see those perspectives as incompatible. AMA PRA Category 1 credit(s) ™. George 14:23 Well, multiple.

IT 121
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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And one of the parts of that was actually doing physicals for the students and putting them in job placements. So this is a podcast going at the geriatricians and palliative care providers. Hearing aids, you had six big manufacturers of hearing aids.

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

GeriPal

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? This hypothesis Played itself out in an interesting way, Ali John 11:15 Thinking about total pain and addressing physical, emotional, social, and spiritual issues. I love that.

Illness 109
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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

What do we do to very concretely provide heat shelters and cool shelters? Ruth: And then to answer your question also about the different providers as far as nurses and physicians and respiratory therapists and pharmacists, most schools of medicine, nursing and all those other fields are including some climate change in their curriculum.