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Agitation Podcast Series Episode 5: Management of the child with mental health problems who is boarded in the ED

PEMBlog

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together.

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

FDA Law Blog

Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e., Software in a Medical Device, or SiMD). Therefore, a firm should first determine whether its product meets the statutory definition of a medical device. Special 510(k)s.

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

The Clinical Problem Solvers

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility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 identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. KP Medical Device Consulting LLC

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

FDA Law Blog

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

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

GeriPal

Management of chronic pain in the elderly: focus on transdermal buprenorphine. We got some really special guests with us. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. And how am I going to manage their pain? Transcript.

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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.

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