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. Regular health check-ups are proactive visits to your healthcare provider when you are not experiencing any specific symptoms or ailments. What are Regular Health Check-ups?

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Preventive Care Preventative Care Mental Health Healthcare 52

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. Essentia Health partners with Second Harvest Northland to provide emergency food access.

Family Physician 52

Family Physician Community Family Families 52

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The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Sponsors considering the use of DMCs (or DSMBs, DSMCs, IDMCs) should carefully consider the recommendations and advice provided in this draft guidance, even prior to its finalization.

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Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

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The Clinical Problem Solvers

OCTOBER 23, 2019

The “Clinical Reasoning Corner” will provide an introduction to the topics that keep our reasoning rooted in the core principles of clinical problem solving. Pre and posttest probabilities provide a framework that helps us decide which diagnostic tests to send, interpret their results, and prioritize our differential. Let’s dive in!

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Clinic Diagnosis Diagnose Utilities 52

Family Physicians of Greeley

JUNE 16, 2023

In this blog, we will provide you with practical tips to help you navigate insurance and healthcare costs effectively. Review the coverage provided, including deductibles, co-pays, and co-insurance. Understand the network of healthcare providers covered by your plan and any limitations or restrictions.

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Rao Doctor

APRIL 29, 2025

The enhanced digestibility means that your body can utilize the nutrients more effectively, leading to improved overall health. Sprouts are rich in vitamins, minerals, and antioxidants, supporting metabolic health and aiding digestion. This can lead to less bloating and discomfort compared to consuming traditionally cooked beans and grains.

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FDA Law Blog

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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Medical Electronics Manufacturing Utilities 64

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. Upper bound of 95% CI ≤ 2.5 CaOx: Mean RSS ≤ 6.0;

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Utilities Manufacturing Provider Individual 59

FDA Law Blog

JUNE 27, 2023

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 ). As we discussed in our prior blog post, there needs to be a better way to understand the outcome of FDA’s review.

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PEMBlog

SEPTEMBER 20, 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. 2017;186:87-94.e16.

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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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Clinic Clinical Practice Provider Utilities 64

Vascular Physician

DECEMBER 2, 2020

Removing the valves provides a clear path for forward moving blood and further decreases the risk of venous hypertension. 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.

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FDA Law Blog

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. FDA), and to generate data in a format that would streamline FDAs review.

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Consulting Manufacturing Utilities Provider 52

FDA Law Blog

APRIL 30, 2024

This hardly provides clarification and seems to limit the topics that could utilize this method of feedback. However, Table 1 states that if the SIR request is received within 60 days of the FDA “marketing submission letter” FDA would, resources permitting, have the meeting or provide written feedback within 21 days.

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Utilities Provider Medical IT 64

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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Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

MAY 13, 2024

Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps. However, based on our experience reviewing device premarket submissions and engaging with FDA, we have found that reviewers have not embraced it in practice. percent of examples.

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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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Asthma Electronics Utilities Clinical Practice 52

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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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) It is completely relieved by rest and most commonly affects the calf, buttock, hip, and thigh. (1)

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Referral Hypertension Primary Care Utilities 40

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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Medical Provider IT Manufacturing 59

FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

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Manufacturing Utilities Government Provider 52

FDA Law Blog

MAY 27, 2024

Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills. 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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FDA Law Blog

SEPTEMBER 16, 2024

with the goal of providing better service to stakeholders interested in early engagement regarding innovative manufacturing technologies. This will include, by November 2024, a more streamlined process, tracking, more timely review of meeting requests, and communication with requesters by providing periodic updates.

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Manufacturing IT Supply Chain Provider 59

FDA Law Blog

OCTOBER 5, 2022

CDRH’s website provides a link to request access to the CCP ( here ). The tracking feature is useful to sponsors during the review process to ensure alignment with the Center on timelines and review status, and it will only grow in its utility now that all 510(k) types can be tracked.

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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. I am in no way, shape, or form a financial professional, nor does this site provide formalized financial advice.

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FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. Rather than modify the existing FDR guidance and issue separate guidance on consolidated proceedings, FDA has issued a single draft guidance covering both topics.

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FDA Law Blog

NOVEMBER 7, 2024

One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

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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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Electronics Physicals Provider Utilities 40

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 Blog

DECEMBER 6, 2024

This could occur during an End-of-Phase 2 (EOP2) meeting if a Phase 2 study is expected to provide primary evidence of safety and effectiveness. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

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Clinic Provider IT Electronics 59

FDA Law Blog

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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Healthcare Professional Utilities Provider IT 52

FDA Law Blog

JUNE 27, 2024

Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. By Larry K. 21 U.S.C. § at § 64B16-27.810(2).

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Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., We previously blogged on the draft guidance here.

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PEMBlog

SEPTEMBER 27, 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. JAMA Pediatr. Hosp Pediatr.

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FDA Law Blog

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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FDA Law Blog

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.” .

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