FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

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FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes.

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Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone.

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GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A. The illness narratives suffering, healing, and the human condition. Naomi: Yes, I do. Everybody Hurts by REM.

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PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Updated 2023 Jul 17]. So my special guest host on this episode is a trainee in pediatrics and medical genetics. You can contact her via email at egroopman@childrensnational.org.

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FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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PEMBlog

JANUARY 16, 2025

Clin Toxicol (Phila) 2023; 61:453. As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide. You can either get one little individual canister of nitrous, or a big canister which costs about 120 to 120. Updated February 26, 2024.

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GeriPal

APRIL 6, 2023

-Alex Practice-PC Program Information: UCSF’s Practice-PC program is now accepting applications for the 2023-2024 year. Practice-PC is an intentionally interprofessional and cutting edge year-long group continuing education course in palliative care for working professionals from all disciplines, in the Bay Area. The theme is death.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Then take a moment to reflect on your unique plate. Food has the power to regenerate the new you! The world of diets and dietary theories is complicated and can be overwhelming. Protein has many functions in the body, aside from just giving us energy.

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Vida Family Medicine

MARCH 1, 2023

This week, February 27-March 5, 2023, marks National Eating Disorder Awareness Week. At Vida Family Medicine we offer primary care services to individuals in recovery from eating disorders. If you or someone you love is suffering, I hope that this information will help you find the resources you need to find recovery.

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GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? To what extent is the rise of tech in San Francisco to blame for our local rise in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What are the highest yield interventions and policy changes?

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GeriPal

DECEMBER 21, 2023

Summary Transcript Summary We’ve talked a lot about comprehensive dementia care on the GeriPal podcast but while the evidence is clear that these programs work, the uptake has been limited largely because there hasn’t been a strong financial case for it. It requires a fight. It’s been going on for many decades now. Malaz: I love it.

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GeriPal

SEPTEMBER 14, 2023

In addition to discussing these outcomes, we also discuss: The history of the hospital-at-home movement. The practicalities of how it works including who are good candidates, where does it start (the ED?), what happens at home, do you need a caregiver, what happens if they need something like imaging? How is it financed and what comes next?

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GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Start with a story as Carly did in her Op Ed. Stories trump data. Write to your congressperson. Before we do, I think, Joe, you have a song request for Alex. Joe: I do. Eric: Wait, which version? But not Space Oddity.

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