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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. Draft Guidance III.B.2(f) 2(f) at 9-10. More specifically, the prohibition includes when a “third party (e.g.,

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

GeriPal

Ab: I learn from them, and I tell sometimes the family members that the person with dementia, your loved one, is fine and you are replaying the event that happened a week ago and you’ve replayed that event 100 times and that’s causing a distress. How do we move on? Sometimes actually memory causing more harm than good.

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

GeriPal

And our next guest is Amy Linsky, who’s a physician and researcher at the VA Boston Healthcare System and associate professor at Boston University University. So acupuncture, Tai Chi, Yoga, mindfulness and physical therapy, chiropractor. Emily, welcome to the GeriPal Podcast. Emily 00:23 Thanks for having me. Alex 00:24 Great.

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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. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. And nurses and other healthcare practitioners knew nothing about it. Over-the-counter hearing aids: What will it mean for older Americans?

IT 102
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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. Eric: And anything else from the history or the physical that’s going to help you around the differential of the sleep problem? And that’s a very miserable place to be. But okay, that’s better. Here’s a little bit, just a little bit.

Illness 85
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Episode 213: Antiracism in Medicine Series – Episode 13 – Centering Asian Americans: Racism, Violence, and Health

The Clinical Problem Solvers

Appreciate how intergenerational trauma may surface amongst Asian-Americans, and how these intergenerational relationships may also offer fertile ground for generating understanding. In the healthcare space, it can also result in a lack of data collection to demonstrate and understand issues faced by these groups.

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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. AMA PRA Category 1 credit(s) ™. Carmen: Thank you.

Community 114