PEMBlog

JUNE 26, 2025

Evaluate clinical findings to determine the need for operative intervention versus observation in stable pediatric patients with soft versus hard signs of vascular or aerodigestive injury. In terms of assessing the patient with a penetrating neck injury, it all starts with the ABCs. Is the patient’s airway patent?

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Management Transportation Patient-Centered IT 59

FDA Law Blog

JULY 17, 2024

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

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Common Sense Family Doctor

FEBRUARY 28, 2025

Family physicians are being squeezed by two accelerating trends: (1) too few of us to care for the growing US population and (2) the rising number of tasks that we are asked to accomplish for each patient. hours per day, with more than one-half of that time (14.1 hours) allocated to preventive care. hours) allocated to preventive care.

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Primary Care Family Physician Preventative Care Preventive Care 52

The Direct Doctors Difference

DECEMBER 8, 2023

A recent article featured on the medical blog, www.Kevinmd.com , highlights some super important reasons as to why you might consider seeing a doctor who is not affiliated with a hospital or large system. In addition, when patients have testing done at in-hospital labs and facilities, the costs are higher than stand-alone centers.

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Primary Care Primary Care Doctor Hospital Referral 52

FDA Law Blog

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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Medical Patient-Centered Healthcare Specialization 119

ABIM

JUNE 12, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The following is a summary of the spring meeting. 4,372 of these (92%) also have a current valid certificate in Internal Medicine.

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Board-Certified Internal Medicine Government Community 52

ABIM

JUNE 17, 2025

She is currently Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center. And it also required a trip to a test center where I spent the entire day. The post The LKA is a practical approach to lifelong learning first appeared on ABIM Blog.

Internal Medicine 40

Internal Medicine Board-Certified Patient-Centered Specialization 40

Logansport Memorial Hospital

APRIL 23, 2024

In this blog article, Dr. Scott Marsh, our podiatrist here at Logansport Memorial, shares some tips to keep your feet healthy. For example, numbness in your feet may be a sign of diabetes or swelling could indicate high blood pressure. Pain in your feet is not normal. If you have diabetes, see your podiatrist for regular check-ups.

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Appointment Diabetes Patient-Centered Specialization 52

FDA Law Blog

MAY 29, 2025

As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. Notably absent from FDAs announcement were any details about the technology that was deployed in the completed pilot program.

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Manufacturing Patient-Centered Medical Management 102

Priority Physicians

JANUARY 20, 2025

But if you’re a patient of a direct primary care (DPC) practice , you don’t need to guess about orthopedic pain management. Unfortunately, traditional care doctors often resort to the two easiest options for patients with joint or back pain: They send the patient for imaging or refer them to a specialist.

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Management Primary Care Physician Primary Care Patient-Centered 52

FDA Law Blog

FEBRUARY 20, 2023

It permanently bans the company from trafficking-in patient data on several fronts. Through our FDA-focused lens, we see a possible roadmap as FDA’s Center for Devices and Radiological Health (CDRH) increases its resources, guidances, and enforcement emphases in the connected digital device space.

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Patient-Centered Telehealth IT Government 105

FDA Law Blog

MAY 27, 2025

and Director of FDAs Center for Biologics Evaluation and Research, Vinay Prasad, M.D., The stated purpose of them is to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.

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Patient-Centered Patients IT 110

Priority Physicians

JANUARY 27, 2025

Find a caring primary care doctor: As a direct primary care physician, I devote time to sit down with patients and learn about their lifestyles, hopes, desires, worries, and concerns. 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.

Primary Care Doctor 52

Primary Care Doctor Primary Care Board-Certified Physicals 52

Vascular Physician

OCTOBER 26, 2021

What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. Most patients lie on their backs or sit up just slightly.

Patient-Centered 52

Patient-Centered Diabetes Treatment Plan Insurance 52

FDA Law Blog

DECEMBER 4, 2023

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). 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. at 62,341.

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Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology.

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IT Nurse Practitioner Patient-Centered Government 59

FDA Law Blog

JUNE 3, 2025

Houck We appreciate receiving feedback on our blog posts. tablets to patients over the course of many months. However, the 2022 Clinical Practice Guideline, which updated the CDCs 2016 Guideline, notes that its recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care.

Clinical Practice 59

Clinical Practice Patient-Centered Patients Clinic 59

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law Blog

JANUARY 13, 2025

These are listed in Table 1 of the final guidance: Almond Black walnut Brazil nut California walnut Cashew Filbert/Hazelnut Heartnut/Japanese walnut Macadamia nut/Bush nut Pecan Pine nut/Pinon nut Pistachio Walnut (English, Persian) Missing from this list are several tree nuts that FDA had included in the non-exhaustive list in that draft guidance.

Patient-Centered 105

Patient-Centered IT Patients 105

FDA Law Blog

DECEMBER 22, 2022

The site offering the treatment, the Judge Rotenberg Educational Center, and parents of patients that were treated with an ESD for self-injurious or aggressive behavior filed a Petition for Review in the D.C. By Jeffrey N. Gibbs & Sara W. Circuit of FDA’s Final Rule banning the ESD specifically for those purposes. . §

Patient-Centered 114

Patient-Centered Education Government IT 114

PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

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Families Family Hospital Patient-Centered 102

FDA Law Blog

NOVEMBER 6, 2024

As the Court explains, an orphan drug may not be the “same drug” as the same active moiety under the Orphan Drug Act and FDA’s longstanding implementing regulations if one is “clinically superior” than the other by way of greater efficacy, greater safety, or major contribution to patient care (“MC-to-PC”). This case followed.

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Clinic IT Patient-Centered Consulting 111

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog.

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IT Hospital Patient-Centered Individual 124

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Patients Patient-Centered Clinic Medical 59

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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Clinic Provider IT Utilities 105

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. Background.

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Manufacturing Patient-Centered Healthcare Utilities 83

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.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

DECEMBER 13, 2023

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.”

Patient-Centered 59

Patient-Centered Medical Patients IT 59

FDA Law Blog

OCTOBER 14, 2024

California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.

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Clinic Patient-Centered Asthma Patients 59

FDA Law Blog

AUGUST 28, 2023

As many individuals are already users of wearables and have mobile devices, there is a desire from the patient perspective to be able to use their own devices, which they are comfortable using, and to avoid the hassle of having two devices throughout a trial.

Clinic 59

Clinic Patient-Centered Medical IT 59

FDA Law Blog

SEPTEMBER 23, 2022

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

Medical 52

Medical IT Patient-Centered Clinic 52

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic Community 52

FDA Law Blog

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.

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Clinic Relationship Provider IT 64

Priority Physicians

FEBRUARY 3, 2025

Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice. MORE BLOGS ← PREVIOUS NEXT → Learn more about membership with Priority Physicians For more details on our services and the concierge care we provide to our members, contact us today. What Does THC Do?

Board-Certified 52

Board-Certified Primary Care Doctor Primary Care Individual 52

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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Provider Manufacturing IT Medical 64

FDA Law Blog

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. We have blogged about this controversy in previous posts (see e.g., here and here ).

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Manufacturing Patient-Centered Government Hospital 59