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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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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 FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., By Adrienne R. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know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

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

GeriPal

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? 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. I’m guessing not.

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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

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Ali John 24:35 In clinical trials. James 00:32 Good afternoon.

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