FDA Law Blog

OCTOBER 27, 2024

This lawsuit has FDA and the homeopathic health community looking at the same provisions of the 2020 CARES Act from vastly different perspectives. The next step in this shift of policy was FDA’s withdrawal in late 2019 of its 1998 Compliance Policy Guide (“CPG”) 400.400, discussed here. It’s a dessert topping; no, it’s a floor wax.

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Annals of Family Medicine

NOVEMBER 20, 2024

2019) frameworks for implementation and evaluation. Setting and dataset: Community-based practice. Analysis: We completed a thematic inductive-deductive analysis of the interviews using the Dedoose software. Initial coding was based on the RE-AIM and Proctor et al. Population studied: Older adults aged 65 years and above.

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Common Sense Family Doctor

DECEMBER 14, 2024

in 2019, with 78% receiving radiation therapy and 22% undergoing surgery. A 2019 AFP editorial provided more guidance for estimating and having conversations about life expectancy with older patients. ** This post first appeared on the AFP Community Blog. Watchful waiting refers to clinical observation only. in 2000 to 59.8%

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: School-based outbreaks often precede increased incidence of acute respiratory infections in the greater community. Objective: We evaluated acute respiratory infections (ARI) among school-aged children in a southcentral Wisconsin school district over 8.5 Outcome Measures: Pathogen identification.

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Physician's Weekly

JUNE 19, 2025

Hospital Consumer Assessment of Healthcare Providers, Systems, and Patient‑Experience scores —and word of mouth—suffer when bias is perceived, jeopardizing both reimbursement and community trust. Systemic strain was obvious. Safety net at capacity. Action Steps Key recommendations from the study team included: Build anti‑stigma reflexes.

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The Clinical Problem Solvers

OCTOBER 18, 2022

The ways to remedy the negative impacts of incarceration are to incarcerate fewer people and to invest in communities. Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration.

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

This year’s episode, our fourth conducted at SGIM, is focused on the importance of qualitative research and the role it plays in antiracism research, community-based work, and scholarship. During this episode, we hear from Dr. S. Gutterman, S., & Ubel, P. Accuracy of Physician Estimates of Out-of-Pocket Costs for Medication Filling.

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Reflections of a Grady Doctor

JUNE 26, 2021

I got promoted to full professor in 2019. I got promoted to full professor in 2019. But let me share another reason why I was so pumped about it: Did you know that, as of 2019, there were 38,975 individuals who've achieved the rank of full professor at US medical schools? Hey everybody! I hope all of you are doing well.

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The Clinical Problem Solvers

JANUARY 18, 2021

Understand that collective action and a focus on community, rather than individualism, are most effective in combating racism and achieving health equity. One of the biggest barriers to health equity is the narrow focus on the individual and a failure to see health as a widespread community issue.

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FDA Law Blog

JANUARY 15, 2024

FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. At an October 2019 Meeting , FDA explained the application process and provided assurances that decisions would be made on each specific product in a submission—not the submission in its entirety.

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FDA Law Blog

SEPTEMBER 30, 2022

These remarks by Dr. Dunn and his Summary Review offer insights into the practical application of the FDA’s December 2019 draft guidance on substantial evidence of effectiveness (as we will discuss further below). By Frank J. Sasinowski & James E. Hyman, Phelps & McNamara, P.C.’s

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The Clinical Problem Solvers

APRIL 3, 2023

During this episode, we hear from Dr. Nav Persaud, a staff physician in the Department of Family and Community Medicine at St. Additionally, Indigenous communities experience lower life expectancy, higher burden of disease, and lower socioeconomic status compared to non-Indigenous Peoples.

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PEMBlog

MARCH 4, 2025

In this episode we dive into the resurgence of Mycoplasma pneumoniae an atypical bacterial cause of community-acquired pneumonia thats making waves in pediatric emergency medicine. Mycoplasma pneumoniae as a Cause of Community-Acquired Pneumonia in Children. Clin Infect Dis 2019; 68:13. Plus, well discuss whether M.

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BMJ

JULY 17, 2020

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. Yet, as Tenkorang 7 made the point, it is simply not enough to only implement approaches at the community level.

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CDOCS

MARCH 15, 2021

& We participate within our dental community in educational meetings and events, which builds our trust in the specialist. Communicating with empathy, through careful word choice, tone of voice, and body language, can be very reassuring and help the patient feel comfortable with their decision.</span></span></p>

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FDA Law Blog

JUNE 15, 2022

billion annually, and continued the same reimbursement cuts for 2019. In 2019, we blogged that the District Court found for the plaintiffs, holding that CMS did not have the statutory authority to make such a change without first conducting a hospital acquisition cost survey data. CMS estimated a savings of $1.6 See 42 U.S.C.

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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

MAY 2, 2022

Session directed federal prosecutors to weigh all relevant considerations, including enforcement priorities set by the Attorney General, seriousness of the crime, deterrent effect of criminal prosecution and cumulative impact of particular crimes on the community. 15 and 16, 2019). 26, 2022, (01:06:35). 21 U.S.C. § Jefferson B.

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FDA Law Blog

JUNE 23, 2021

Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. So, we crafted the Patient-Focused Drug Development, or PFDD, a commitment that was agreed to in PDUFA V.

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PEMBlog

SEPTEMBER 24, 2024

Bronchopulmonary sequestration is a rare type of congenital lung malformation (CLM) in which a section of lung tissue is nonfunctional and does not communicate with the normal tracheobronchial tree. 2019 Apr 1;48(4):e169-e174. Resolution of symptoms in patients with community-acquired pneumonia treated on an ambulatory basis.

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Annals of Family Medicine

NOVEMBER 20, 2024

Objective To provide a comprehensive overview of primary care use among community-dwelling persons with dementia in Quebec from 2018 to 2020. Population Studied Community-dwelling persons aged 65 and older with a prevalent diagnosis of dementia on March 1st of 2018, 2019, and 2020. 60.8%, 60.2%, and 58.8%

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 24(b) (emphasis added). EKRA Issue.

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FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 24(b) (emphasis added). EKRA Issue.

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The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Know your community resources.

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The Clinical Problem Solvers

DECEMBER 20, 2021

Understand how engaged community-based work, centered on trust and accountability, has supported the health of communities served by Oakland, CA’s Asian Health Service. By appreciating the impact of factors affecting entire communities, we can be better positioned to act upon them.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Identify realistic solutions to drug policy reform that promote health equity among marginalized communities living in the United States. Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today.

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Permanente Medicine

JUNE 25, 2025

This convenience addresses the biggest barriers patients face, particularly in communities historically underserved by preventive care and for those who have less contact with health care. But at its core, this program is about communicating with patients and understanding their needs. A third of U.S. in 2000 to 79.8%

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GeriPal

MARCH 9, 2023

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Psychedelics have been used by communities around the globe for hundreds of years (or more). And yet there are reasons for caution. Ethical issues , including colonization of psychedelics by big pharma.

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GeriPal

MARCH 24, 2023

Usually I don’t put a lot of background on this podcast, but I got to … in November of 2022, Ava Kofman, along with ProPublica, published … well I won’t want to say great, published an article in The New Yorker that I think it was divisive in the hospice and palliative care community. Is it you, Ira? Eric: Great.

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The Clinical Problem Solvers

OCTOBER 11, 2021

It’s our collective responsibility to explain it, to define it, to communicate it in effective ways to physicians, to healthcare systems, to the public at large and in detail, with data and with narratives, all the ways through which racism impacts our healt h.” It gives us a sense of how different things can be.” 2020;324(3):231-232.

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The Clinical Problem Solvers

MAY 30, 2022

Pearls Black and Indigenous birthing people are 3-13 times more likely to die in childbirth, with the rate varying by location and level of investment in communities. The exact statistics vary by location and by the overall level of investment in services such as childcare and parental leave within each community.

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The Clinical Problem Solvers

NOVEMBER 6, 2023

Harrison, a community organizer and trans theorist, and Dr. Psyche A. As an editor, movement media and narrative strategist, and storyteller, Harrison uses their extensive history as a community organizer—which began in 2014 during their first year at Morehouse College—to frame their political thought and cultural criticism.

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Common Sense Family Doctor

DECEMBER 4, 2024

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019.

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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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Illness IT Patient-Centered Patients 109

GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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My Green Doctor

MAY 29, 2025

Without closing this gap, healthcare systems everywhere will struggle to meet rising demands, especially in vulnerable communities where climate change is accelerating inequality and suffering. And perhaps most importantly, we provide the information to the healthcare community to educate their patients. So what’s the path forward?

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GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Cochrane Database of Systematic Reviews Review.

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