November, 2023

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Sleep: The Magic of Rest and Repose

Intuitive Intelligence

Sleep is a fascinating journey into the subconscious and unconscious world. Have you ever wondered why we spend roughly one-third of our lives sleeping? Why do some folks cherish it while others grapple with it being a waste of time? Let’s unravel the mystery of what happens when we sleep. Sleep: A Waste of Time or a Vital Necessity? The first question that often arises is whether sleep is important enough to be taking up ⅓ of our day.

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Prostate Cancer: Unmasking the Risk and Reality

East Cary Family Physicians

Men often exhibit a certain stoicism when it comes to their health, occasionally avoiding necessary check-ups and overlooking early warning signs. This phenomenon often leads to delayed diagnoses and missed opportunities for early intervention. Prostate cancer, a formidable adversary that affects one in every eight men during their lifetime, serves as a poignant reminder of the necessity for proactive healthcare practices.

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Stephen Siegel, MD: Designated UroLift® Center of Excellence

Boulder Medical Center

The designation recognizes that Dr. Siegel has achieved a high level of training and experience with the UroLift System and demonstrated a commitment to exemplary care for men suffering from symptoms associated with Benign Prostatic Hyperplasia (BPH), also known as enlarged prostate. The post Stephen Siegel, MD: Designated UroLift Center of Excellence appeared first on Boulder Medical Center.

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Unraveling Lymphedema: Causes, Risk Factors, and Treatment Options

Vascular Physician

Unraveling Lymphedema: Causes, Risk Factors, and Treatment Options Your lymphatic system is responsible for maintenance of fluids throughout your body. When your lymphatic system does not function properly, fluids can accumulate in certain areas of your body causing swelling. Lymphedema occurs when protein-rich fluid that is supposed to be drained by the lymphatic system builds up and causes an area to swell.

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RSV: Recognizing RSV Symptoms in Adults

Doctor On Demand

Updated January 22, 2025 Respiratory Syncytial Virus (RSV) is a common respiratory infection that can affect individuals of all ages, but it is particularly prevalent in young children and older adults. Understanding the symptoms of RSV is crucial, especially as they are similar to those of COVID-19 , the common cold, or the flu. Let’s explore the distinctive signs of RSV in adults, highlight the similarities with other respiratory illnesses, and emphasize the importance of seeking professional

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Substance use disorder treatment available at Direct Doctors

The Direct Doctors Difference

It is easy to think that substance use can't affect us - until it does. Substance use disorder does not discriminate and should not be shamed or shunned. It is a disease just as much as diabetes or asthma. That is why Dr. Delaporta offers substance use disorder treatment as part of her primary care practice. Like other chronic illnesses, there are medications available to help with substance use disorder.

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Embracing Surrender: A Guided Journey

Intuitive Intelligence

Lately, I’ve been getting many questions about the concept of surrender, a subject that seems counterintuitive to the culture of control that we live in. In a world that glorifies busyness and accomplishment, the idea of surrender seems absurd. Recognizing Surrender’s Challenge Surrender can be difficult because it can feel like relinquishing control.

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Episode 310 – WDx Episode #26: “You are Resilient, even if You Don’t Know It”

The Clinical Problem Solvers

[link] Sharmin, Kaylin, and Jane are joined by Dr. Risheen Reejhsinghani, cardiologist extraordinaire, Clinical Associate Professor at Stanford, and Associate Program Director of the cardiology fellowship. They discuss her journey through medical training as an international medical graduate, how her love for cardiology developed, and how her career has evolved to allow her to combine her passions for medical education and mentoring into her daily work.

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Should you have a coach? Greg Pawlson, Beth Griffiths, & Vicky Tang

GeriPal

Summary Transcript Summary Coaching is in. During the later stages of the pandemic, it seemed every other person, and particularly the junior faculty in our Division, were either being coached, in training to coach, or coaching others. When I was a junior faculty, coaching wasn’t a thing. Sure, Atul Gawande wrote about coaching in surgery – having someone observe you and coach you on your technical skills- but that’s a far cry from the coaching programs focused on empowerment that are e

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Varicocele: Understanding Symptoms, Diagnosis, and Treatment Options

Vascular Physician

Varicocele: Understanding Symptoms, Diagnosis, and Treatment Options Varicocele is a condition that occurs when the veins within the loose pouch of skin that contain the testicles become swollen or enlarged. The veins located inside the testicles are intended to move oxygen-depleted blood back to the heart, however, a varicocele develops when the blood pools in these veins instead of exiting the veins.

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Fracture Fridays: You can dance if you want to

PEMBlog

The case A self-proclaimed dance team superstar presents after injuring her foot at a regional competition. She tried to finish the routine after landing awkwardly. But was having difficulty bearing weight. She applied ice overnight and despite ibuprofen is still in pain, and presents to the ED the next day.On her exam the neruovascular exam is normal, and she has pain along the proximal edge of the 5th metatarsal.

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The Angry Email

33 Charts

The angry email is a timeless problem among young leaders and managers. Something gets us upset and we impulsively take to the keyboard to try to fix it. What comes out is typically edgy and direct. Usually there’s frustration buried between the lines. I’ve had the chance to work with several young physician leaders over the past couple of years.

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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law Blog

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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Episode 311: Spaced Learning Series – Hypercalcemia

The Clinical Problem Solvers

[link] Episode description: The spaced learning series team discusses a case of severe hypercalcemia, seizure, and vision loss. Featuring: Simone Vais Moses Murdock Valeria Roldan Schemas Hypercalcemia Download CPSolvers App here RLRCPSOLVERS Click here to view the weekly episode recap email!

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The Future of Geriatrics: A Podcast with Jerry Gurwitz, Ryan Chippendale, and Mike Harper

GeriPal

Summary Transcript Summary What does the future hold for geriatrics? I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. But, it’s also hard not to be bullish on the future of the field to see the consistent strides geriatrics has made in the last two decades in improving care for older adults.

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Chronic Venous Insufficiency: Causes, Symptoms, and Treatment

Vascular Physician

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. When this happens, blood can flow backward and lead to pooling in your legs. It's estimated that CVI affects up to forty percent of people in the U.S. and can cause a variety of uncomfortable symptoms including pain, heaviness and swelling.

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Cough, Congestion, & Runny Noses: A caregiver education video

PEMBlog

This excellent video was developed at Cincinnati Children’s and features some of my colleagues. It provides a step by step overview on how to deal with cough and congestion, including a really well done section on nasal suctioning with saline. It would be perfect to share with a family with a child with a URI or bronchiolitis.

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Burnout is a sign

33 Charts

There’s lots of talk about physician burnout. There’s even more talk about how we get rid of it. Everyone has a solution. But the problem with the conversation is that burnout is a sign , not a disease. Burnout is the downstream result of a number of complex upstream problems. But it’s rarely the problem. Focusing on fixing burnout is like trying to eliminate fever during a COVID outbreak.

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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog

By Riëtte van Laack & Anne K. Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, officers, or agents of a corporation for violating the CPSA.

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Episode 312: Neurology VMR – Frequent Stumbling

The Clinical Problem Solvers

[link] Episode title: Episode 312: Neurology VMR – Frequent stumbling Episode description: We continue our campaign to #EndNeurophobia, with the help of Dr. Aaron Berkowitz. This time, Valeria presents a case of frequent stumbling to Nilayan and Subhangi. Neurology DDx Schema Valeria Roldan Valeria is a medical student at Universidad Peruana Cayetano Heredia.

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November is Diabetes Awareness Month

Family Physicians of Greeley

Diabetes is and is the seventh leading cause of death in the United States. Did you know approximately 311,554 (6.9% of the adult population) in Colorado have diagnosed diabetes, and that every year approximately 34,291 people are newly diagnosed? In addition, there are approximately 117,000 people who have undiagnosed diabetes and an astounding 1,444,000 people who have prediabetes.

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The Link Between Diabetes and Peripheral Arterial Disease

Vascular Physician

The Link Between Diabetes and Peripheral Arterial Disease Diabetes is a serious health condition that causes a person's blood sugar to rise because their body does not produce or use insulin properly. Peripheral artery disease (PAD) occurs when the arteries that carry blood away from a person's heart to other areas of their body become narrow, most commonly in the legs and feet.

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Oral Rehydration therapy: A caregiver education video

PEMBlog

This incredible and informative video was developed at Cincinnati Children’s and features some of my colleagues. It provides a tremendous overview on how to do oral rehydration therapy in a step by step fashion and it is definitely something that I think you can share with your patients on your next shift.

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Suboptimization as a Healthcare Strategy

33 Charts

Optimization has become a defining feature of modern healthcare. We optimize, review, tweak, and measure our systems and ourselves against a super-optimized standard. Better, faster, safer, more productive, efficient and effective. We’re always looking for improvement. And for good reason. 21st century healthcare has worked to prioritize safety and quality improvement, and the results have been remarkable.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

By Allyson B. Mullen & Gail H. Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N. 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 ).

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Episode 308 – RLR – 105 Fever

The Clinical Problem Solvers

[link] Episode description Reza and Rabih discuss a case of a young woman with a fever of 105 Student discount [link] IMG discount Use coupon code RLRIMG at check out [link] Click here to view the weekly episode recap email!

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Blood, Hope and Faith.

Blood, Sweat, and Tears

I looked up at the black sky and saw darkness. I hadn’t seen the sun in a few weeks. When I left home, it was dark. When I arrived home, it was dark. On post call days, seeing the sun felt abnormal. It burned. I was on call. I packed my bag and drove to work in silence. I had this funny thought on my mind recently. We are so good at preparing how to live.

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Understanding Pelvic Venous Disorders

Vascular Physician

Understanding Pelvic Venous Disorders Pelvic venous congestion is a condition that occurs when the veins in your pelvis do not function properly. The blood that is returning from below your abdomen moves slowly, which causes blood to pool and varicose veins to form. This can lead to uncomfortable symptoms that can negatively impact your quality of life, including pelvic pain.

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FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting

FDA Law Blog

By Allyson B. Mullen & Jeffrey N. Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. The notice ( here ) indicates that FDA plans for the panel to “discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of t

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HPMers to Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference

FDA Law Blog

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), as well as other experts from FDA, DOJ, and the private sector. HPM Director Anne Walsh will moderate a panel discussion on “Due Diligence and Mitigating Securities Violation Risks for Emerging Life Science and Novel Food Companies.

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Going to 11: New Subsections at CDER’s Office of Pharmaceutical Quality Are Important Piece of FDA’s Inspection and Enforcement Strategy

FDA Law Blog

By John W.M. Claud — The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). It is the latest item on a long list of similar initiatives that have marked 2023. Those efforts add up to a clear message to industry that FDA is looking beyond CGMP when it evaluates drug makers.

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Join Us for ACI’s Advanced Legal Regulatory and Compliance Forum on OTC Drugs

FDA Law Blog

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. Designed for in-house legal and compliance counsel, industry executives, and private practice attorneys working for the OTC drug industry, the event will welcome distinguished industry thought leaders – including from the National Advertising Division and FDA – to share their expertise and strategic insights.

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The Streams Have Been Crossed: FTC Enters FDA Territory

FDA Law Blog

By Sara W. Koblitz — “ Human sacrifice! Dogs and cats living together! Mass hysteria! ” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. It’s so exciting that we might actually have an answer to some lingering questions about listability!

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Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?

FDA Law Blog

By Mark A. Tobolowsky & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022. Although fairly short and light on substance, it has the potential to reshape the industry in ways that are sorely needed.

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FDA Proposes to Ban Brominated Vegetable Oil in Food

FDA Law Blog

By Sophia R. Gaulkin & Riëtte van Laack — For any of our readers seeking recommendations on which drinks pair well with turkey this Thanksgiving, certain fruit-flavored beverages may be off the table. Earlier this month, FDA issued a proposed rule that would revoke 21 C.F.R. §  180.30 , its interim authorization of the use of brominated vegetable oil (BVO) in in fruit-flavored beverages.

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HP&M Recognized by Best Law Firms® as National Tier 1 – FDA Law and Regional Washington, DC Tier 1 – FDA Law (2024 Edition)

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the firm has been selected to the 2 024 edition of Best Law Firms. Firms included in the 2024 Best Law Firms ranking are recognized for professional excellence with persistently impressive ratings from clients and peers. To be considered for this milestone achievement, at least one lawyer in the law firm must be recognized in the 2024 edition of Best Lawyers.

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It’s About Time: FDA’s Proposed Rule to Amend Prior Notice Regulations

FDA Law Blog

By Sophia R. Gaulkin & Riëtte van Laack — On October 31, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. More specifically, the proposed rule, if finalized, would: Amend 21 C.F.R. § 1.281(b)(10) to require that prior notice for articles of human and animal food arriving by international mail include the name of the mail service and tracking number; and Amend 21 C.F.R. §§

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