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How Gut Health and Digestion Influence Cholesterol Levels

Imperial Center Family Medicine

Your digestive system doesn’t just process food; it also influences cholesterol screening levels in your bloodstream. The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Contact us today at 919-873-4437 or online to book a consultation.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles. By Adrienne R.

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. separate patient labeling).

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

GeriPal

Screening for addressing hearing loss should be an integral part of what we do in geriatrics and palliative care, but it often is either a passing thought or completely ignored. How to screen for hearing loss. Eric: And how do we screen for it? Communication techniques we can use when talking to individuals with hearing loss.

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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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? Now they’re getting psychedelic experiences, you know, and transformation in a consulting office. So I can say anything I want. I am not sticking my foot in my mouth.

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