Physician's Weekly

JUNE 24, 2025

“Given the wide use of statins for the prevention of cardiovascular disease, it is likely that their use in this population has also conferred benefits in combating infections and sepsis,” wrote study author Keliang Xie, MD, PhD , of Tianjin Medical University General Hospital, and study coauthors.

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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. Producers), & Burnett, C.,

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Reflections of a Grady Doctor

JUNE 26, 2021

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? That was a huge deal for me as an academic physician. waits while you guess* 307.

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FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). Valentine & Larry J.

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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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The Clinical Problem Solvers

DECEMBER 16, 2020

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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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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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. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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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. a study designed to be externally-controlled).

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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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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). Retracted] had a super fun survey that really focused on my interests and individuality outside of medicine. You’re probably thinking “What the hell! It all adds up.

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FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §

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FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. 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.

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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. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of the approximately $13,000 annual copay. The Medicare program would pay most of the remaining $225,000 in annual cost.

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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)). HCT/Ps that meet the four criteria under 21 CFR 1271.10(a), a) or the SSP exception. Robbins , 519 U.S.

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FDA Law

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions. Fiscal Year.

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FDA Law

AUGUST 9, 2021

Farquhar — On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. The Federal Register Notice specifically addresses medical imaging products, like those at issue in the Genus case. Koblitz & Douglas B.

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FDA Law

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. attorneys’ offices since 2019, the Complaint seeks monetary and permanent injunctive relief ( see 21 U.S.C. §§ 832(f)(1) and 882(a)).

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FDA Law

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 220(e)(2). 18 U.S.C. § 18 U.S.C. §

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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. We’ll be keeping out eye out for the applicant’s response to the PTO’s request. sections l56(a)(5) and 156(f)(1).

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FDA Law

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. By Asking Them. When a Patient Speaks (Sept. 25, 2014).

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FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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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. If they’re a beginning fellow, that’s a very different coaching situation than coaching the chief medical officer or the president of a medical center. It’s also a lot what stage of career they are.

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GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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The Clinical Problem Solvers

APRIL 5, 2022

Do you have a medical respite center? Push back against individual narratives that blame individuals for systemic injustice. Calac, Victor A. Lopez-Carmen, MPH, Naomi F. Know your community resources. Our guests emphasize that physicians must be familiar with community resources. Can you refer your patient there? 3.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). Objective: To determine whether resident-facility language concordance/discordance is associated with the odds of potentially inappropriate prescribing of antipsychotics (PIP-AP) in LTC.

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BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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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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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Family physicians are central to managing the medical needs of older adults. This specialized workforce has not yet been classified in health administrative data, limiting our understanding of their individual and medical practice characteristics. focused), primary care activities (i.e.,

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Medical Xpress

FEBRUARY 7, 2023

Suicide and self-harm adversely affect individuals, families, and society at large. Other than causing mental distress, they also lead to productivity loss and soaring medical expenses. In 2019, losses associated with suicide reached $490 billion.

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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?) provision in only English +/- Spanish), limitations of medical technology (i.e.,

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The Clinical Problem Solvers

OCTOBER 11, 2021

These gaps are not a product of lifestyle choices, biology or individual behaviors. Association of Social and Economic Inequality With Coronavirus Disease 2019 Incidence and Mortality Across US Counties. Structural competency: theorizing a new medical engagement with stigma and inequality. Episode Takeaways: 1. Soc Sci Med.

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GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder.

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Medical Xpress

DECEMBER 20, 2022

Since December 2019, more than 60 million people have been diagnosed with coronavirus disease 2019 (COVID-19) worldwide, while approximately six million individuals have died as a result of the disease. Hospital treatment was required in about 10%–20% of COVID-19 patients, with this proportion decreasing over time.

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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. Brian: For the use of substances like psilocybin and LSD in medical care, or at least in investigational treatments, I like to call it psychedelic therapy. Or is that your medications causing that? Or does it?

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GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I talked about lack of prestige and respect, and I talked about how healthcare system leaders and medical school deans don’t always seem to value the field of geriatrics.

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