Joy in Family Medicine Coaching

DECEMBER 27, 2024

It was emphasized that well-being is a shared responsibility—systems must provide adequate resources and a healthy environment to prevent burnout, which is an occupational issue. So, this blog series will explore how investing in physical health —a critical component of overall well-being— can make an impact.

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FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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FDA Law Blog

JANUARY 10, 2023

The new Guidance provides the first update in 25 years on FTC’s thinking regarding substantiation and disclosures for health-related claims. The new Guidance provides the first update in 25 years on FTC’s thinking regarding substantiation and disclosures for health-related claims. By Riëtte van Laack & Ricardo Carvajal — On Dec.

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Sound Physicians

JUNE 9, 2025

Finally, caregivers—often family members—play a critical role in educating the care team, flagging barriers to care once out of the hospital, and providing necessary insights into the bigger picture. Posted in Hospital Medicine Share Article Subscribe to the Sound Physicians Blog A trusted source for todays healthcare needs.

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Sound Physicians

MARCH 12, 2025

Increasingly a valuable option for rural hospitals, tele-ICU provides access to higher acuity care and support to emergency and hospital medicine clinicians who are called to the ICU. While we primarily partner with our own Sound specialty teams , we also work independently with employed and other outsourced clinical teams.

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FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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Sound Physicians

NOVEMBER 19, 2024

It is, by design, built into the ways we educate, train, and support our clinical leadership. Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. Excellent leaders rise to the occasion when opportunities are open and available to them.

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Sound Physicians

NOVEMBER 5, 2024

Sound Critical Care is at the forefront of bringing coordinated leadership and clinical excellence to hospital ICUs and the patients within them. For smaller or rural hospitals, this can mean supplementing patient care with tele-ICU clinicians, available 24/7, to keep our providers from stretching too thin.

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Sound Physicians

OCTOBER 30, 2024

I went to the University of Toronto and finished my Bachelor of Science there in 2013. I wanted to get back to where we were, to give back to the program that gave my career a place to start, and to provide stability to my fellow providers. When prospective providers visit Mercy Hospital of Buffalo team.

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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. Community Partnerships: Mayo Clinic collaborates with local food banks to offer mobile food distributions.

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FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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FDA Law Blog

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines.

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Louisville Lectures

MAY 5, 2023

These will focus on delivering just-in-time algorithms, practical clinical knowledge and board tips on high-yield topics. These lectures will be provided by the University of Louisville Internal Medicine residents. Visit Little Lectures Welcome to the LL Blog! We are hoping to continue this tradition by adding the LL Blog.

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PEMBlog

MARCH 20, 2024

After searching 177 keywords using FOAMSearch, the top 50 FOAM websites on the (now defunct) Social Media Index, and seven additional PEM-focused blogs, we reviewed and quality assessed 441 blog posts on relevant topics. For each blog, we extracted information such as author names and date of publication. Happy learning!

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FDA Law Blog

MARCH 31, 2025

had sued FDA, HHS, the FDA Commissioner, and the Secretary of Health and Human Services last year, alleging that the LDT Rule conflicted with the text, history, and structure of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Clinical Laboratories Improvement Amendments (CLIA). By Steven J. Gonzalez On March 31, 2025, U.S.

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Dr. Zaar

MAY 20, 2025

Today, virtual care provides quick, convenient access to expert endocrinologists. In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. During the appointment, you discuss your symptoms and clinical records. What Is Hormonal Therapy?

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FDA Law Blog

DECEMBER 12, 2022

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations. But, for software products, it is often not straightforward to address this question by simply referring to the statutory definition of a device.

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FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. The Draft Guidance provides specific examples illustrating the application of each scenario. By Adrienne R.

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Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only. A recent analysis of the U.S.

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FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2 million over four years.

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FDA Law Blog

JUNE 2, 2025

RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Some of the claims that FDA cited as being for diagnostic use included Simple and patient-friendly measurement of hormone profiles, Provides accurate, low level detection, and Can be performed also by patients.

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Barton Associates

MAY 29, 2025

These crucial healthcare providers can be found in almost every healthcare setting, including, but not limited to: Hospitals Private Practices Urgent Cares Higher Education Corporate Clinics Telehealth Services Insurance Companies Correctional Facilities Indian Health Service (IHS) Facilities Why is the physician shortage growing?

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FDA Law Blog

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. Javitt & Steven J. demographic bias of data fed to algorithms).

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FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. In this post, we focus on the proposed changes themselves, and the many questions the agency leaves unanswered.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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ABIM

MAY 7, 2025

Blueprints provide an outline of what content will appear on an assessment and the relative percentage of the assessment covered by each topic area. During this process, Item-Writers will often provide feedback and societies provide their own perspectives on behalf of their members.

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The Motivated MD

NOVEMBER 19, 2024

For many who follow the blog regularly, you likely have noticed that I haven’t published a blog post in quite some time (a month or two). True we have a fulltime nanny, but we still both work full-time clinically and still wish to have a steady hand in our children’s lives. Keeping a personal finance blog is a tricky thing.

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Finance Education Family Families 52

Imperial Center Family Medicine

APRIL 21, 2025

This blog will help you understand basic terms, concepts, and expectations related to cholesterol screenings. The screening provides your total cholesterol level but doesn’t differentiate between HDL, LDL and VLDL. This blood test provides a complete cholesterol breakdown by measuring individual lipid components.

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FDA Law Blog

JUNE 14, 2021

It would require also that CMS hold a public meeting to solicit recommendations on updating existing Clinical Laboratories Improvement Amendment (CLIA) regulations related to clinical testing laboratories. The Centers for Medicare and Medicaid Services (CMS) implements CLIA , largely based upon regulations issued in 1992.

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FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

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East Cary Family Physicians

OCTOBER 20, 2023

In this blog, we’ll explore the importance of Breast Cancer Awareness Month, focusing on early detection, prevention, and the vital role of regular screenings in women’s healthcare. At East Cary Family Physicians, we believe that knowledge is power. The average risk of a woman in the U.S.

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FDA Law Blog

JUNE 26, 2024

A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission. eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions.

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Priority Physicians

JANUARY 20, 2025

Priority Physicians Provides Care for Musculoskeletal Injuries But before you rush that sprained ankle to urgent care, consider this: At Priority Physicians, we have fellowship-trained sports medicine doctors with the proper credentials to handle musculoskeletal injuries knowledgeably. Contact your DPC physician immediately.

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FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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The Clinical Problem Solvers

MAY 14, 2020

Then things started to get a little bit different… His chest x-ray had some peripheral infiltrates, and the emergency department providers ordered a CT scan. The pretest probability is composed of the overall concordance of the clinical data with a specific illness script as well as the prevalence of that disease within the community.

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FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., Instead, FDA’s determination of whether a single study plus confirmatory evidence could provide substantial evidence is to be “based on relevant science.”

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