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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

APRIL 28, 2025

Still, we know that sometimes the final decision comes down to a single factor: cost. While we’ve earned our reputation over the decades for our clinical excellence in hospital medicine , we’ve also earned — somewhat unfairly — a reputation for being more expensive than our competitors. Physician compensation is tied to quality of care.

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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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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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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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Sound Physicians

OCTOBER 30, 2024

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. They see our cohesiveness, they see the bonds, and they see the way our providers value each other.

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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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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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FDA Law

JUNE 18, 2025

The Commissioner will use “specific criteria” to award the vouchers, and information will be provided in the near future on how companies can apply for a CNPV and “indicate their alignment with the FDA Commissioner’s criteria to meet national priorities.” Easily interpreted clinical trial endpoints (e.g.,

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Common Sense Family Doctor

JANUARY 19, 2025

The American Academy of Family Physicians (AAFP) maintains that clinical privileges should be based on documented training and experience rather than the physician’s specialty. From 2016 to 2021, the percentage of screening colonoscopies performed by family physicians decreased from 11.3%

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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).

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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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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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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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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. It is easy to start.

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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. An accompanying blog post touts the new Guidance as potentially “one of the most important documents you’ll read in 2022.” The FTC’s new Guidance does not have the force and effect of law.

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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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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

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. Clinical Decision Support Software. Step 6: Is the software function intended to provide clinical decision support?

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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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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

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. Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

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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. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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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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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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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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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. Is an MRI Always Needed?

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FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e.,

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FDA Law Blog

DECEMBER 21, 2022

Baumhardt, Senior Medical Device Regulation Expert — In our previous blog post , we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight.

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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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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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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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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. 2014;58(2):258-274.

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