Remove Consulting Remove Management Remove Manufacturing Remove Screening
article thumbnail

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.

DO 52
article thumbnail

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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. By Adrienne R. Many sponsors want to reduce animal testing and, therefore, welcome the approach. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know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

article thumbnail

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? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management. So I can say anything I want. So 5ht2 was.

Illness 107