Physician's Weekly

JUNE 22, 2025

Researchers examined the effects of semaglutide on body weight, health status, and mood over 1 year in individuals with HF and obesity. They assessed 122 individuals with HF and obesity who were treated consecutively with semaglutide between January 2019 and August 2023.

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Annals of Family Medicine

NOVEMBER 20, 2024

Methods: We identified two closed cohorts of PLWD on March 3, 2019 (pre-pandemic) and March 1, 2020 (pandemic) and stratified them by community and nursing home settings Outcome measures: Rates of intensive care unit admissions. Results: Community cohorts included 160,288 (pre-pandemic) and 166,392 (pandemic) individuals.

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Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied: Women with singleton pregnancies who received prenatal care from a family physician MaRNet-FP sentinel between July 1, 2019 and December 31, 2022 and who also delivered within that timeframe were included. Significance was set as p < 0.05.Dataset:

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: The impact of the COVID-19 pandemic on individuals with schizophrenia who are admitted to academic medical centers (AMCs) has not been previously reported. from Oct 2019 to Dec 2023. The study is divided into three periods: pre-COVID (Oct 2019 to Mar 2020), COVID (Apr 2020 to May 2023), and post-COVID (Jun 2023 to Dec 2023).

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Integrated Care News by CFHA

MAY 19, 2025

The full process of MBC (Collect, Share, and Act) supports a shared decision-making framework that is inherently therapeutic, with the aim of improving treatment outcomes as well as promoting the overall wellness of individuals and populations. (2, 1, 8, 9) d. Journal of Evaluation in Clinical Practice, 18(1), 104–110. Anderson, K.N.,

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Physician's Weekly

JUNE 15, 2025

This study utilized data from the 8th Korea National Health and Nutrition Examination Survey for 2019 and 2021 to investigate the relationship between OSA and health-related quality of life (HRQoL). High-risk individuals who were economically inactive, consumed alcohol, or engaged in low physical activity also showed a lower quality of life.

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Annals of Family Medicine

NOVEMBER 20, 2024

Methods: We conducted a case-control study in US outpatient settings that enrolled patients aged 18 to 75 years with acute LRTI and controls without respiratory symptoms between 2019 and 2023. All patients underwent PCR testing for 46 bacterial and viral pathogens by the CDC Respiratory Branch Laboratory.

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Physician's Weekly

JUNE 14, 2025

Safety was evaluated as a secondary endpoint. The results showed that between August 21, 2019, and June 10, 2022, 1,244 participants were randomized to receive pembrolizumab plus enzalutamide (n=621) or placebo plus enzalutamide (n=623). Prior use of abiraterone was allowed. by blinded independent central review. months (range 6.1–39.8

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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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Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied: Individuals with gonorrhea and chlamydia positive tests. Results: Between 1/1/2019 and 12/31/2021, 4385 persons were treated for chlamydia and gonorrhea were documented within the MedStar system. Setting: MedStar Health, a multidisciplinary and multispecialty health care system in the mid-Atlantic US.

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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.

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Plum Health

JULY 6, 2023

As of 2019, 49.6% individual), and 1.4% Furthermore, the study provides a snapshot of the sources of health insurance coverage in the United States. of the population was covered by employer-sponsored group insurance, 19.8% by Medicaid, 14.2% by Medicare, 5.9% by non-group (i.e., by military. However, 9.2%

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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. J Health Care Poor Underserved.

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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 Blog

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 Blog

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 Blog

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 Blog

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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FDA Law Blog

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. FDA gives no rationale for interpreting the apparently broad statutory term “medical information” in such a restrictive manner.

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FDA Law Blog

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), Robbins , 519 U.S. 452 (1997); see also Kisor v.

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FDA Law Blog

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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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!

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FDA Law Blog

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 Blog

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 Blog

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.

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FDA Law Blog

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 Blog

JUNE 29, 2022

As for CDER, although rescission of a BTD has not been a particularly common occurrence, we have seen what seems to be an uptick in FDA’s issuing Notices of Intent to Rescind, even as requests and grants have slightly declined from the 2019 highs. Fiscal Year. Total Requests Received. Granted . Rescinded .

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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. 2019 Jun 25;73(24):3234]. J Am Coll Cardiol. 2019;73(24):3153-3167. doi:10.1016/j.jacc.2018.11.005 2018.11.005 Hoffman KM, Trawalter S, Axt JR, Oliver MN.

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FDA Law Blog

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 Blog

MAY 8, 2023

Although FDORA gave FDA express authority to allow PCCP , FDA had already been considering creating a mechanism for manufactrurers to prespecify modifications for AI/ML-based software subject to 510(k) premarket notification and de novo classification for several years.

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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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FDA Law Blog

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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FDA Law Blog

MAY 17, 2022

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. and more likely 15-20.

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FDA Law Blog

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. FDA’s Latest PFDD Guidance Puts What Is Important to Patients at the Center of Drug Development. By Asking Them. 18, 2018).

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FDA Law Blog

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 if additional testing is required or justification would suffice), responsible individuals, proposed timelines, and any clarifying questions for FDA. Average Number of Industry Days to MDUFA IV Decision 54.69

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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. ” Eric: It strikes me that there also seems to be a difference between coaching a team, like many of us are familiar with, and this individual coaching, although there may be group coaching as well. We learn in context.

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