East Cary Family Physicians

JULY 26, 2023

In this blog, we will explore the significance of regular health check-ups and how they contribute to your overall well-being. When you visit your healthcare provider routinely, they get to know you better, understand your medical history, and can tailor their advice and treatments to suit your specific needs.

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Family Physicians of Greeley

JUNE 16, 2023

Understanding your insurance coverage, managing medical bills, and finding affordable healthcare options are essential for maintaining your health without breaking the bank. In this blog, we will provide you with practical tips to help you navigate insurance and healthcare costs effectively.

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Physician's Practice

JUNE 26, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Telehealth has evolved into a vital service channel, yet many practices struggle with inadequate setups. Reynolds June 23rd 2025 Article Navigating the health tech landscape requires strategic diligence to avoid hidden costs and ensure seamless integration in medical practices.

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PEMBlog

MAY 27, 2024

What if a boy band from the year 2000 wrote a song about he management of status asthmaticus and then someone made a video and then posted that video to a Pediatric Emergency Medicine blog. You’d think that would be pretty silly right? Lyrics Difficulty breathing, asthma’s bad tonight albuterol and atrovent Dexamethasone All right!

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Physician's Practice

JUNE 23, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Navigating the health tech landscape requires strategic diligence to avoid hidden costs and ensure seamless integration in medical practices. The health technology gold rush is back on, and sales reps know where to find you. Yet a single misstep can wipe out months of margin.

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Minnesota Academy of Family Physicians

FEBRUARY 20, 2025

Streamline Referrals: Utilize technology like the Hunger Vital Signs tool and the Minnesota Food Helpline to connect patients directly to mobile food units, emergency food programs or Supplemental Nutrition Assistance Program (SNAP) enrollment services. Do you have resources to share with other members?

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The Clinical Problem Solvers

FEBRUARY 27, 2022

Demonstrate the utility of an illness script in clinical reasoning 4.- So the illness script we developed as a first-year medical student will evolve over time. This will solidify your knowledge of the condition and increase the utility of your Illness script. Today we are going to talk about Illness scripts ! So let’s dive in!

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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FDA Law Blog

AUGUST 4, 2022

In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

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FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. DMC charters have also grown longer and more detailed. DMC charters have also grown longer and more detailed.

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FDA Law Blog

MAY 22, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. By Jeffrey N.

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Vascular Physician

DECEMBER 2, 2020

The flow through the graft is then checked using doppler, which utilizes sound waves to ensure that blood is readily moving through the newly placed graft. Overall, this procedure may seem quite complicated, but a large team of medical experts are involved in the care of each patient.

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FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

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FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N. percent of examples.

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FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

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FDA Law Blog

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 ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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FDA Law Blog

DECEMBER 12, 2023

The recommendations in the draft guidance address: The wording of UTH claims based on RSS for use on adult maintenance cat food labeling; The RSS criteria to substantiate those UTH claims; and The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food.

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Pfizer’s Petition to SCOTUS.

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FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R.

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FDA Law Blog

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Vascular Physician

FEBRUARY 23, 2020

Ultrasound and CTA can also be utilized to evaluate blood flow through vessels and narrowing of arteries. Thus, all pa-tients with PAD symptoms should be assessed for risk of cardiovascular disease. (4) Gangrene can be a life-threatening condition if it is allowed to progress.

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FDA Law Blog

MAY 27, 2024

HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. She also specializes in medical device software and digital health. With her return to the firm, she can now utilize her recent in-house experience to help HPM’s diverse client base solve complex problems.

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Physician's Practice

JUNE 25, 2025

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. Dr. Baum was the columnist for American Medical News for more than 25 years.

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The Motivated MD

OCTOBER 3, 2024

Many who follow this blog know that I reside in South Carolina. Wiped-out grocery stores, medications unfilled, spoiled food, hours-long lines for gasoline, and impatient citizens pulling firearms on each other, escalating tensions in an already tumultuous time. However, this is a personal finance blog, and for me, it goes beyond that.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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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. This week, we are tackling all things related to lifestyle creep. These posts may contain affiliate links.

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FDA Law Blog

JUNE 27, 2024

paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. A pharmacist is prohibited “from filling a prescription for a controlled substance when he either knows or has reason to know that the prescription was not written for a legitimate medical purpose.” By Larry K.

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FDA Law Blog

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

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Physician's Practice

JUNE 9, 2025

Reynolds Blog Article Physicians Practice Physicians Practice June 2025 Volume 3 Issue 3 Physicians navigate challenging payer negotiations, sharing success stories of securing approvals for innovative, cost-effective treatments. Neil Baum, MD Payer negotiations are like David confronting Goliath.

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Physician's Practice

JUNE 24, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article Thoughtful design in medical practices enhance patient experience, boost staff productivity, and improve online reviews without major renovations. First impressions in medicine form long before anyone touches a stethoscope.

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Physician's Practice

JUNE 6, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article These nine cost-effective strategies can boost employee morale and retention in medical practices, addressing turnover without breaking the budget. Turnover is eating medical practices alive. Transform interactions into lasting connections. Price, M.D. Price, M.D.

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Physician's Practice

JUNE 27, 2025

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. I refer to this thought transference as the Bathroom Experience (BE), a powerful metaphor for how seemingly minor details can dramatically impact patients’ perceptions of a medical practice.

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