The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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FDA Law Blog

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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Aspiring Minority Doctor

MARCH 26, 2021

December 2020 The official plastic surgery release date was December 4, 2020 and to my delight, I received an interview! It is with great happiness and exhilaration that I announce I finally matched! Even better, I matched into an INTEGRATED PLASTIC AND RECONSTRUCTIVE SURGERY RESIDENCY PROGRAM in MIAMI!!!!

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The Clinical Problem Solvers

OCTOBER 18, 2022

[link] CPSolvers: Anti-Racism in Medicine Series Episode 18 – Remedying Health Inequities Driven by the Carceral System Show Notes by Ayana Watkins October 18, 2022 Summary: This episode highlights the history and roots of the carceral system, as well as its far-reaching impacts on the health of women and children today.

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FDA Law Blog

MAY 3, 2021

In July 2020, DEA stated as a justification for increasing registration fees that it planned to increase the number of scheduled regulatory inspections and investigations. 44,710, 44,716 (July 24, 2020). Thus, non-compliance can be very costly, so it is more important than ever to dot every “i,” cross every “t.”.

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FDA Law Blog

MAY 8, 2023

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g.,

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GeriPal

NOVEMBER 9, 2023

A 2020 RCT of coaching for primary care physicians shows that coaching improves burnout well-being during the intervention and has a sustained duration at 6 months of follow up. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? How does it differ from therapy?

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FDA Law Blog

JUNE 22, 2022

In the second case, occurring from January to May 2020, a registered nurse, admitted to daily tampering of fentanyl vials and hydromorphone injectables wherein she removed the drugs from the vials replacing them with saline solution. DEA regulations require “adequate security” but do not specially require cameras in health care facilities.

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FDA Law Blog

MAY 3, 2021

In July 2020, DEA stated as a justification for increasing registration fees that it planned to increase the number of scheduled regulatory inspections and investigations. 44,710, 44,716 (July 24, 2020). Thus, non-compliance can be very costly, so it is more important than ever to dot every “i,” cross every “t.”.

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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? But before we do, do you have a song request? I think Kellie, do you have it? Alex: Yeah.

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FDA Law Blog

SEPTEMBER 30, 2022

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates. of America v.

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FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). The stability profile of the product must be considered when a product is shipped to a participant’s home.

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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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Physician's Weekly

JUNE 19, 2025

The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

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ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*.

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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

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. Is it you Lyndsay?

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ABIM

JUNE 11, 2025

Erin Bonura, MD, Chair, ABIM Infectious Disease Board The Infectious Disease Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on March 25, 2025. The group discussed some of Dr. McDonald’s updates in greater detail.

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GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. 2023 Dec 20:S1524-9042(23)00202-3. 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. Accepting This Poem by Mark Nepo [link] Saks, N.,

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FDA Law Blog

JANUARY 4, 2022

This includes a November 2020 Special Fraud Alert wherein OIG explained its enforcement focus regarding speaker programs. (We On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. Department of Health and Human Services (OIG). Other jurisdictions like D.C.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. Epub 2020 Dec 3. Academic Psychiatry , 45 (1), 78–83. link] Castillo, E. DeBonis, K. Braslow, J. T., & Rohrbaugh, R.

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Georgetown Pediatrics & Family Medicine

FEBRUARY 10, 2023

In addition to a special day called Valentines, I would like to bring awareness to why we should keep our hearts healthy. According to the CDC, “About 697,000 people in the United States died from heart disease in 2020– that’s 1 in every 5 deaths”. Your heart is undoubtedly one of the most important organs in your body.

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ABIM

MAY 30, 2025

A workgroup convened in 2020 found that the existing practice categories candidates could choose were inadequate to the real scope of community practice and proposed updates drawn from the American Medical Association and the Diplomate Professional Profile. Rodriguez, MD , Chair of the Nephrology Board, and John C.

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GeriPal

MARCH 30, 2023

But before we go into that topic, I think, Liz, you got a song request for Alex. Liz: That’s right. It’s called the Beginning of the End and it’s by Weezer. Eric: Why’d you pick this song? Liz: So I used to be the drummer in a punk rock band. And so- Eric: Get out of here. Liz: No, it’s true. Eric: Lucky Strike.

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GeriPal

DECEMBER 5, 2024

So has a special resonance for, I think, a lot of people who are Tragically H ip fans. One final note on the song request: About 20 years ago I took an epidemiology course as part of a Masters program. The instructor, Fran Cook , gave all the students a survey without explanation. We answered the survey and handed it in.

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GeriPal

APRIL 10, 2025

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Why do so many (most, all??)

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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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GeriPal

FEBRUARY 20, 2025

Mariah discussed her JAGS paper on applying a trauma-informed approach to home visits. Kate and Ashwin talked about their research on the prevalence of lifetime trauma and its association with physical and psychosocial health among adults at the end of life. Mariah, welcome to the GeriPal Podcast. Mariah 00:29 Glad to be here. Here we go.

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GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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FDA Law Blog

JUNE 21, 2022

In that legislation, Congress instructed FDA to publish proposed OTC hearing aid rules by August 2020 and to finalize those rules within 180 days after the closing of the public comment period for those proposed rules. Directing FDA to issue rules isn’t out of the ordinary.

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GeriPal

APRIL 21, 2022

The impossiblity which is life, which is everything, and death, which is the end of life. As Mary Oliver tells us In Blackwater Woods , and I’m paraphrasing here, we must to hold it to our bones, knowing our lives depend on it, and when the time comes, to let it go. To let it go. . Poetry helps us grapple with our own experiences of illness.

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Malaz: I love it.

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §

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Physician's Weekly

JUNE 12, 2025

From 2017 to 2019, during Trump’s first term, Blase served as Trump’s special assistant for economic policy. The report said this might have increased the improper payment rate as high as 25%, based on the rates found in 2020 and 2021, when a high number of eligibility checks were included in the agency’s methodology.

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