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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog

Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” It will be provided in a future eSTAR update. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

However, the diagnostic approach used to determine changes in clinical management of renal disease (i.e. Additionally, research has shown that using symptom-prompted modifications to management, in the context of shared decision-making, can improve outcomes. 2016 Jul;91(7):916-20. September 12, 2018. Race Matters? N Engl J Med.

Clinic 52
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The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law Blog

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. as a de novo special control or in a guidance document for a specific device type). By Jeffrey K.

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Buprenorphine Use in Serious Illness: A Podcast with Katie Fitzgerald Jones, Zachary Sager and Janet Ho

GeriPal

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Management of chronic pain in the elderly: focus on transdermal buprenorphine. We got some really special guests with us. And how am I going to manage their pain? Article on buprenorphine in the elderly.

Illness 103
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Palliative care for cancer: Podcast with Jennifer Temel and Areej El-Jawahri

GeriPal

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families.

Illness 111
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Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. 2016 Jan;37(1):3-15; quiz 16-7, 47. Pediatr Rev. Pediatrics.