FDA Law

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. Pfizer’s Petition to SCOTUS.

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FDA Law

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website.

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FDA Law

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” telemedicine and telehealth solutions (e.g.,

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FDA Law

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In this safety communication, FDA states: The U.S. 21 U.S.C. §

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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. June 25, 2025 By Neil Baum, MD Fact checked by Keith A. If your patients are unhappy with care then they probably won't come back to your practice.

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The Motivated MD

OCTOBER 3, 2024

Many who follow this blog know that I reside in South Carolina. However, this is a personal finance blog, and for me, it goes beyond that. I do not mean to paint such a grim picture, but I want to provide a healthy dose of realism. Tornados can strike down on a moment’s notice, and flooding can devastate our infrastructure.

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FDA Law

JULY 7, 2022

The first was to develop labeling beyond the DFL and the second was to propose “additional conditions that a consumer must fulfill” with the examples self-selection tests utilizing a mobile app or a requirement for the consumer to affirm they have watched a video or read text about use of the drug.

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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. Their thoughts might jump to, “If they can’t keep their bathroom clean, what about their attention to my healthcare records?

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Management Private Practice Patients Medical 52

FDA Law

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” By Larry K. When the pharmacist noted “verified” on the prescription, the expert opined that “is not sufficient to actually resolve a red flag.”

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

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. Health Aff (Millwood).

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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. This blog will discuss what early adopters do to implement innovative and exciting practices. Breaking them can lead to problems, fines, and even incarceration.

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Management Patient-Centered Appointment Patients 52

FDA Law

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

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PEMBlog

SEPTEMBER 13, 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.

Patients 52

Patients Screening Illness Physicals 52

FDA Law

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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IT Education Utilities Patient-Centered 40

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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Family Medicine DO Family Families 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Folate (folic acid) helps the body form red blood cells.

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Referral DO Family Medicine Primary Care 40

FDA Law

JANUARY 4, 2023

The provision amends the Federal Food, Drug, and Cosmetic Act section 502 to provide explicit protection for conveying certain information about products in development to payors, including unapproved uses of approved products. 2617, the “ Consolidated Appropriations Act, 2023 ,” was signed into law by President Biden on December 29.

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Patients Provider IT Utilities 64

FDA Law

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies. intended use population.

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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. And that’s a lot easier if all providers were X waivered too.

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PEMBlog

APRIL 26, 2023

Studies demonstrate that utilizing one of these storage methods can reduce the suicide and unintentional gun deaths in children by up to 54%. [ Kristen ] Great question. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. You can purchase these for about $25-100.

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Family Families Mental Health Healthcare 52

FDA Law

MAY 3, 2022

By Dara Katcher Levy — A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion.

IT 52

IT Medical Patients Utilities 52

FDA Law

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

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GeriPal

DECEMBER 19, 2024

This episode of the GeriPal Podcast is sponsored by the Zuckerberg San Francisco General Hospital Division of Hospital Medicine , which is committed to providing outstanding, compassionate care to all patients, advancing health equity, and fostering excellence in hospital medicine. I want to expand it from just the maid area.

Illness 101

Illness Mental Health IT Patient-Centered 101

GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. So at our cancer center, we have physicians, advanced practice providers. Or the article that, the fast food article, to use the parlance from the blog post.

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Patient-Centered IT Patients Hospital 119

FDA Law

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

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FDA Law

JUNE 1, 2025

While FDA has historically looked at manufacturer promotion, the language in the Federal Food, Drug, and Cosmetic Act (FDCA) provides that it is a prohibited act to cause the misbranding of a drug in interstate commerce. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.

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Healthcare Professional Manufacturing Healthcare Utilities 59