Physician's Weekly

JUNE 24, 2025

Using the Medical Information Mart for Intensive Care-IV database, the authors reviewed health record data from 20,230 adults with sepsis treated in the Beth Israel Deaconess Medical Center ICU between 2008 and 2019. Statin exposure during the ICU stay defined the treatment cohort.

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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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Plum Health

JULY 6, 2023

As of 2019, 49.6% individual), and 1.4% This flexibility can significantly improve the work-life balance for employees and increase their overall job satisfaction. The SOA study provides some interesting data points. For instance, it shows that DPC can lead to a decrease in healthcare costs in various areas. by Medicaid, 14.2%

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FDA Law

OCTOBER 2, 2023

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

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The Clinical Problem Solvers

APRIL 3, 2023

The dehumanization of individuals of color at the margins of society by the healthcare system is not simply a thing of the past, and is certainly a persistent phenomenon. Cindy Gladue, Brian Sinclair, and Joyce Echaquan are three Indigenous individuals who suffered immense harm at the hands of the healthcare system.

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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

AUGUST 9, 2021

As you may remember, Genus sued FDA back in 2019, alleging that FDA’s classification of, and putative regulation of, its barium sulfate products as drug products violated the FDCA because barium sulfate meets the statutory definition of medical device and therefore must be regulated as a device.

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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. Psychological health during the coronavirus disease 2019 pandemic outbreak. Scholars such as Wen et al.

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FDA Law

OCTOBER 11, 2022

Additional guidance on confirmatory evidence is sorely needed as the December 2019 draft guidance spends just two of its 18 pages telling us what FDA thinks of such a key piece of statutory language. Sasinowski & James E.

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Aspiring Minority Doctor

APRIL 17, 2021

For the 2019 cycle, I spent a total of $372, and the total spent on the 2020 cycle was $353 (and I forgot to register for SOAP, so did not participate this year). For the 2019 cycle, I spent a total of $372, and the total spent on the 2020 cycle was $353 (and I forgot to register for SOAP, so did not participate this year).

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FDA Law

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. Background.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

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FDA Law

OCTOBER 14, 2024

The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” 588, 566 (2019)). Defendants may also seek en banc review of the decision from the full Ninth Circuit. Robbins , 519 U.S.

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FDA Law

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Premarket Approval or De Novo pathways). This comparison is misplaced.

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FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000.

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GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. 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? link] Transcript Eric: Welcome to the GeriPal podcast. Indeed, matey.

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FDA Law

JANUARY 6, 2022

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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FDA Law

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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FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

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FDA Law

JUNE 29, 2022

Livornese — Last week, FDA issued a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation” (the Draft Guidance ), authored by CDER, CBER, and the Oncology Center of Excellence (it is interesting, though not surprising, to see the OCE as an author on this document, given the popularity of the program in oncology).

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FDA Law

FEBRUARY 28, 2022

The Agency envisions a range of activities that may enhance the design and conduct of clinical studies through engagement with “patient advisors” – individuals who have experience living with a disease or condition, but who are not study/research participants themselves or caregivers of study/research participants.

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FDA Law

JANUARY 31, 2022

In addition, the Complaint alleges inappropriate dispensing to numerous individuals, multiple DEA recordkeeping violations, improper alteration of prescriptions, and violations Texas law and federal corresponding responsibility obligations required of pharmacists that dispense opioid prescriptions.

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FDA Law

JULY 10, 2023

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. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.

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FDA Law

FEBRUARY 27, 2024

Consequently, because both applications were approved at the same time, both applications represent the first permitted commercial marketing or use of the product or the individual active ingredients, as outlined under 35 U.S.C. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). l 56(c)(4) and 37 C.F.R.

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Patients IT Provider Individual 59

FDA Law

JANUARY 6, 2022

A “health care benefit program” is defined as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”

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FDA Law

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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FDA Law

MAY 17, 2022

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And with “must-pass” FDA legislation, comes a host of riders—pieces of FDA-related legislation not specific to UFA reauthorization, but that folks seek to get added to the UFA bill to address various issues and topics. Becerra.”

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Annals of Family Medicine

NOVEMBER 20, 2024

Specifically, this study aims to identify the proportion and characteristics of individuals with dementia who had no primary care visits and those who had at least one visit with a family physician within a year and to describe the characteristics of persons with dementia who experienced low continuity of care during the same period.

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GeriPal

MARCH 24, 2023

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. And the big question, is hospice losing its way? Is it you, Ira? Alex: Great choice.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

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The Clinical Problem Solvers

APRIL 5, 2022

Push back against individual narratives that blame individuals for systemic injustice. Published April 5, 2019. January 18, 2019. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. Push back against dehumanizing language. Rothstein, R. Silkworm Studio.

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The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. 2020;324(3):231-232. doi:10.1001/jama.2020.9289

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The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) Remember that more deeply understanding your patients can provide meaning!

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GeriPal

MAY 18, 2023

We’ve invited two members who helped update the criteria including Todd Semla and Mike Steinman. We discuss a little history of the Beers criteria, including the original Beers Criteria that was published by the late Dr. Mark Beers, and how it has evolved over the last three decades. Alex: We’re having Beers. We’ll learn about that.

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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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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Significant structural barriers exist concerning access to healthcare for transgender (TG) individuals. Setting or Dataset: Secondary analysis of the CDC state-specific Behavioral Risk Factor Surveillance System (BFRSS) surveys conducted from 2019 to 2022. TG who had depression were approximately 4.4

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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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