Medical Xpress

FEBRUARY 9, 2023

Viral suppression of HIV by antiretroviral medications helps slow transmission of the disease and keep individuals living with it healthy, at times making viral loads so low they are undetectable even on blood tests. were virally suppressed as of 2020. Sixty-five percent of people diagnosed with HIV in the U.S.

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The Clinical Problem Solvers

FEBRUARY 24, 2021

Learning Objectives After listening to this episode listeners will be able to… Recognize the importance of yielding privilege and power to better center marginalized voices and communities through individual, interpersonal, institutional, and systemic actions. Credits Written and produced by: Utibe R.

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Common Sense Family Doctor

FEBRUARY 28, 2025

Since 2020, the starting ages for breast, lung, and colorectal cancer screening were lowered to 40, 50, and 45 years, respectively. Meanwhile, the estimated time needed to provide guideline-recommended preventive care, chronic disease care, and acute care to a nationally representative panel of 2,500 adult patients is an impossible 26.7

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Common Sense Family Doctor

MARCH 15, 2025

A 2022 article in the Harvard Business Review introduced the term sludge to describe “these types of situations in which the design of a specific process consistently impedes individuals from completing their intended action.”

Screening 52

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The Clinical Problem Solvers

MAY 9, 2021

Rather than searching for obscure explanations for inequalities, we must instead recognize the ways that racism impedes health at both individual and structural levels. However it is important to remember that this political invention DOES affect biology because of the way that it creates social inequity.

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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. Int J Soc Psychiatry 2020 (May 21; published online). Front Commun ́2020 (June 12; published online).

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Community Individual Physicals Finance 40

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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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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FDA Law Blog

AUGUST 23, 2022

The study represents the most robust attempt at understanding the performance of serial use of rapid antigen tests for SARS-CoV-2 detection among asymptomatic individuals in the U.S. The low viral loads were most likely due to individuals infected with the Omicron variant. That could happen again.

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FDA Law Blog

JULY 25, 2023

And FDA has had numerous with meetings with individual stakeholders seeking a better understanding of their approach to nitrosamines. Aside from its publications, FDA is continuing to investigate the presence of NDSRIs in drug products, which may lead to more inspections or, at least, heightened expectations for industry.

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FDA Law Blog

DECEMBER 7, 2022

In simple terms from a non-scientist, these gene therapies add functional versions of genes to patients that do not have them, and thus the idea is to have these genes function in the same way as they do in individuals without these disorders. they waned over time), even though patients would have benefited over a shorter duration?

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FDA Law Blog

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Letter from Congress of the United States, to Robert Patterson, Acting Administrator, DEA (Dec. Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. 46,983 (July 21, 2023). b)(5)(i)).

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FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. A promising solution to produce meaningful data is the thoughtful and measured development and introduction of practical digital technology platforms.

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The Clinical Problem Solvers

AUGUST 25, 2020

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives.

Community 52

Community Patient-Centered Relationship Education 52

FDA Law Blog

APRIL 19, 2022

DEA noted that the National Association of Chain Drug Stores (“NACDS”) and three other individuals commented on the proposed rule. DEA noted that the National Association of Chain Drug Stores (“NACDS”) and three other individuals commented on the proposed rule. 1,030 (Jan. at 21,020- 21,021.

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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. Premarket Approval or De Novo pathways).

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GeriPal

AUGUST 4, 2022

My take home from this is that while the most preferred explanation for deprescribing statins and sedative-hypnotics is one focused on the risk of side effects, we also need to individualize it to the patient and the medication that they are taking. Alex: No, I think we did one other super special. Alex: So this is Super special 2.

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FDA Law Blog

SEPTEMBER 19, 2023

Thus, “FTC intends to use its full legal authority” to take action “against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.” Koblitz & Kurt R. But it is not always clear which types of patents are eligible for listing in the Orange Book. Avdel amicus brief).

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FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Gaulkin & Jeffrey N. Wasserstein — The U.S.

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33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. And individual practice styles are fine. More recently health professionals have seen a rise in MyChart messages coming in through the Epic patient portal. Potentially serious.

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FDA Law Blog

NOVEMBER 14, 2022

27, 2020, solely for the purpose of manufacturing hand sanitizer products during the public health emergency is exempt from OMUFA fees. FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. The facility fee applies to a single manufacturing facility. 31, 2021 is subject to the fee for FY 2022. (In

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FDA Law Blog

NOVEMBER 6, 2022

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. At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background.

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FDA Law Blog

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025.

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FDA Law Blog

FEBRUARY 23, 2025

Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance. Notably, FDAs public WL database only goes back to 2020. The guidance includes examples of changes and flowcharts that frequently make their way into formal company procedures. But this guidance has its limitations.

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ABIM

APRIL 24, 2025

Johnson, MD, FACP, FIDSA , Senior Vice President for Academic Affairs, added that ABIM provides program directors with aggregate performance data in their programs and, with permission, individual graduate data so that program directors can make adjustments to the programs as needed. The following is a summary report of the spring meeting.

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FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). The healthy claim has been the topic of much discussion and challenged in consumer class actions.

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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

APRIL 22, 2024

The UN Commission on Narcotic Drugs removed cannabis and cannabis resin from schedule IV of the Single Convention in December 2020. marijuana manufacturers, importers, exporters, and distributors will be required to obtain DEA registrations, and prescriptions will be required for dispensing marijuana to individuals. 811(d) and U.S.

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FDA Law Blog

FEBRUARY 27, 2024

Despite a rather long history of granting multiple PTEs, in 2020, in an about-face, the PTO took the position that multiple PTEs are no longer supported by the statute. FDA-2020-E-1840 (July 13, 2020). FDA-2020-E-1840 (Mar. 2020) , has not yet—and to our surprise—ended up in court. Ezra Ventures LLC, 909 F.3d

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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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FDA Law Blog

DECEMBER 13, 2023

Dr. Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

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Patient-Centered Medical Patients IT 59

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% 60.8%, 60.2%, and 58.8%

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Primary Care Community Family Physician Diagnosis 130

GeriPal

JUNE 8, 2023

We debate the merits of use of CGM in the nursing home and other late life settings (Eric and I argue against CGM and lose). Ozempic is a new fancy med that, by the way, leads to weight loss among celebrities, resulting in shortages of the drug from people using it off-label for that purpose. Listen in to learn more! Nadine: I do. Good choice.

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Diabetes Management Patient-Centered Family 73

FDA Law Blog

MARCH 4, 2024

In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) expanded the notification requirement to include reasons contributing to the discontinuance or interruption (e.g., Early notification can play a role in decreasing the impact and duration of such supply disruptions and product shortages.

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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 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 Blog

JULY 4, 2023

Although all consolidated parties may participate in the FDR or hearing, the number of individuals from each party able to attend the consolidated proceedings in person may be limited because of facility and space limitations. FDA will determine the total number of individuals who can attend the consolidated proceedings in person.

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