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

FDA Law

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. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

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

GeriPal

And one of the parts of that was actually doing physicals for the students and putting them in job placements. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. I don’t see myself in that world.”

IT 102
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Transforming the Culture of Dementia Care: Podcast with Anne Basting, Ab Desai, Susan McFadden, and Judy Long

GeriPal

I think … There’s so few, seriously, from the hospital system and the pathologizing systems to the more social care intervention work that Susan and I really do. We need to learn from them that they have moved on, so how do we not dwell in the past negative events? How do we move on? She had been included.

Community 101
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Deprescribing Super Special III: Constance Fung, Emily McDonald, Amy Linsky, and Michelle Odden

GeriPal

I’m an internist, so when I hospitalize patients, 1 in 8 of my patients now takes pregabalin or gabapentin. You’re in the hospital right now, we can write you a taper, just mention to your doctor, mention to the team that you got this brochure and here’s even a suggestion for how to do it. 1 in 8 in the U.S.

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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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Sleep problems and Insomnia in Serious Illness: A Podcast wtih Cathy Alessi and Brienne Miner

GeriPal

Alex: Here, I thought it was just like a relationship tension and breakup song. I think the classic example is somebody who just came out of the hospital, they’re put on these new medications because they were having problems in the hospital and now they’re home and they don’t need those anymore. Eric: Yeah.

Illness 85
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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Panelists Carmen Quatman and Katie Quatman-Yates have no relationships to disclose. laughter] Carmen, welcome to the GeriPal podcast! Carmen: Thank you.

Community 114