Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

A Collaborative Approach Between Health Care Providers and Community Partners Food insecurity affects thousands of Minnesotans, often contributing to chronic health conditions and overall poor health outcomes. An excerpt follows: 2024-04. M Health Fairview’s Fair Table program ensures convenient access to food during medical appointments.

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Common Sense Family Doctor

FEBRUARY 28, 2025

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 hours per day, with more than one-half of that time (14.1 hours) allocated to preventive care.

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FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed. However, the new guidance suggests that FDA may be recommending, or perhaps acknowledging, a greater degree of its involvement with DMCs.

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Plum Health

MAY 19, 2023

Raquel Orlich treats a Plum Health member Are you a self-employed individual, uninsured, underinsured, or enrolled in a high deductible catastrophic health plan in the Detroit or Royal Oak area? It's not insurance but complements various insurance and health share plans to provide comprehensive coverage.

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The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. We simply cannot. There are not enough hours in the day.

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FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 11, 2023 ( DOJ Press Release ). 21 U.S.C. § 829; 21 C.F.R.

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Imperial Center Family Medicine

APRIL 21, 2025

This blog will help you understand basic terms, concepts, and expectations related to cholesterol screenings. The screening provides your total cholesterol level but doesn’t differentiate between HDL, LDL and VLDL. This blood test provides a complete cholesterol breakdown by measuring individual lipid components.

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FDA Law Blog

SEPTEMBER 24, 2024

Specifically, CDER moved from sharing the reviews of the individual disciplines in the documents available to the public to sharing an Integrated Review which shares the conclusions but much less of the detail of each review. Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject.

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East Cary Family Physicians

JANUARY 30, 2024

In this blog post, we’ll explore the importance of vision screenings, especially during Glaucoma Awareness Month, and how they play a crucial role in preserving your eyesight. By the time individuals experience vision problems, significant damage may have already occurred.

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Vascular Physician

APRIL 22, 2024

Because they come in varying levels of compression, be sure to consult your healthcare provider to ensure that you wear stockings that are appropriate for your needs. When a blood clot occurs in a deep vein in your body (a vein that's not near the surface of the skin), it's called a deep vein thrombosis (DVT).

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Aspiring Minority Doctor

OCTOBER 23, 2021

If you've been following my blog since it's inception in 2013, then you already know how much of an inspiration Dr. Barbara Ross-Lee is to me. Hopefully one day I can give back and serve as an inspiration to someone just like many individuals such as Dr. Barbara Ross-Lee who provided inspiration and encouragement for me :)

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FDA Law Blog

JULY 20, 2021

FTC received more than 700 comments in response to the notice of proposed rulemaking from individuals, industry groups, consumer organizations, and members of Congress. FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the proposed rule. or the Egg Products Inspection Act.

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The Motivated MD

NOVEMBER 19, 2024

For many who follow the blog regularly, you likely have noticed that I haven’t published a blog post in quite some time (a month or two). Last, but not least, I genuinely felt as if I was running out of ways to provide useful and entertaining financial content. Keeping a personal finance blog is a tricky thing.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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East Cary Family Physicians

OCTOBER 20, 2023

In this blog, we’ll explore the importance of Breast Cancer Awareness Month, focusing on early detection, prevention, and the vital role of regular screenings in women’s healthcare. Genetic counseling and testing can help individuals understand their risk. At East Cary Family Physicians, we believe that knowledge is power.

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Vascular Physician

OCTOBER 24, 2022

Because of this, it is common for blood to pool in the individual's leg or for them to develop deep vein thrombosis (DVT), which occurs when a blood clot forms in the deep veins of the leg. If your healthcare provider suspects that you could have May-Thurner syndrome, they will likely use noninvasive imaging studies to diagnose you.

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FDA Law Blog

AUGUST 26, 2021

Which brings us to the FIFA prosecutions, a topic that would not typically be blogworthy for the FDA law blog. By JP Ellison — It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems. The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality.

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FDA Law Blog

SEPTEMBER 28, 2021

The Pfizer-BioNTech COVID-19 vaccine received emergency use authorization (EUA) for the prevention of COVID-19 disease in individuals aged 12-15 in May 2021. Additionally, this recent trial studied a two-dose regimen of 10 µg administered 21 days apart, a much smaller dose than the 30 µg dose used for individuals 12 and older.

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The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. ’ Having a high income and being wealthy are not synonymous. What is Lifestyle Creep?

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FDA Law Blog

NOVEMBER 29, 2023

See our prior blog post on the topic here. Risk-based This guiding principle ensures risk management principles are used to evaluate the individual and cumulative changes over the life of the device. Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks.

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FDA Law Blog

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). The final guidance provides additional discussion with respect to DHTs that meet the definition of a device. Lenz, Principal Medical Device Regulation Expert & Lisa M.

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Vascular Physician

OCTOBER 10, 2022

Hyperbaric oxygen therapy is preferred by medical professionals and patients alike thanks to the many benefits it can provide. During this time, you will be closely monitored by your healthcare provider. Fortunately, hyperbaric oxygen therapy can do just that. What is It Used For? Your body cannot function without oxygen.

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Priority Physicians

JANUARY 27, 2025

We all want to know how to stop fearing the future. Although anxiety appears to be the new malady du jour , much of it is natural and normal. Sometimes, it’s even protective. From an evolutionary standpoint, anxiety is an effective survival mechanism. After all, it saved early man from getting too close to cliffs, which is why we’re here today!

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Vascular Physician

JUNE 12, 2022

Because individuals with claudication are more likely to have a heart attack or stroke, seeking medical care quickly is important. We can help determine if claudication is to blame and create an individualized treatment plan to meet your unique needs. When your arteries are not healthy, your overall quality of life can be affected.

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Vascular Physician

NOVEMBER 28, 2023

These risk factors include: Obesity Smoking Inactivity High blood pressure High cholesterol Family history of diabetes, PAD, or heart disease Symptoms and Complications of PAD It is normal for some individuals with PAD to have symptoms that are mild or not noticeable at all.

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Vascular Physician

NOVEMBER 5, 2023

While some individuals' symptoms may be mild, others can be severe and even disabling. Chronic Venous Insufficiency: Causes, Symptoms, and Treatment Options Understanding Chronic Venous Insufficiency Chronic Venous Insufficiency (CVI) is a condition that occurs when the veins in your legs return blood to your heart as they should.

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FDA Law Blog

AUGUST 23, 2022

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. But the question is, is 80% sensitivity the right place to set the bar?

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FDA Law Blog

AUGUST 2, 2022

Cole providing guidance to U.S. It is worth noting that the CSA provides that HHS medical and scientific findings on drugs are controlling. 21 U.S.C. § 812(b)(1). 3 (July 5, 2022) [hereinafter CRCC Letter]. The “Cole Memo” was a memorandum from General James M. 26, 2022).

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FDA Law Blog

OCTOBER 2, 2023

A brief explainer on confirmatory evidence: how we got here Before we dive into the specifics of the new guidance, we should explain that the statutory standard we allude to is the requirement that an applicant provide “substantial evidence of effectiveness” to obtain approval of an NDA or BLA.

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ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit. ABIM does not contact individual programs with a lower pass rate to initiate changes to the program.

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Family Physicians of Greeley

MAY 17, 2023

In this blog, we will explore effective strategies for improving mental health and nurturing a positive mindset. Surround yourself with supportive and positive individuals who uplift you and provide a sense of belonging. Maintaining good mental health is essential for our overall well-being.

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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

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.” And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

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FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. By Philip Won & Adrienne R. But that is only the beginning.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. By Larry K. Houck Last month the U.S. 81, 86, 251. 81, 89, 251.

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FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA provides definitions for the three datasets.

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FDA Law Blog

AUGUST 9, 2021

While FDA previously regulated all imaging agents as drugs regardless of how they achieve their primary intended purposes, FDA will now “reexamine whether individual imaging agents meet the device definition.” The FDCA definition hinges on the mechanism by which a product meets its primary intended purposes.

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