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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. Section II at 2. More specifically, the prohibition includes when a “third party (e.g.,

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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. And there’s multiple survival analyses looking at incident dementia, and hearing loss is strong, independently associated with the time to event dementia. Hearing aids, you had six big manufacturers of hearing aids.

IT 102
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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. We are already seeing effects and they’re pretty much every body system.