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. M Health Fairview’s Fair Table program ensures convenient access to food during medical appointments.

Family Physician 52

Family Physician Community Family Families 52

FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. DMC charters have also grown longer and more detailed. DMC charters have also grown longer and more detailed.

Clinic 105

Clinic Provider IT Utilities 105

PEMBlog

MARCH 19, 2024

Be sure to check out our previous post on: BRONCHIOLITIS The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. For each blog, we extracted information such as author names and date of publication. How can I use these findings? Happy learning!

Education 52

Education Utilities Provider IT 52

PEMBlog

MARCH 18, 2024

The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. 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.

Education 52

Education Utilities Community Management 52

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.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

Medical 111

Medical Clinic Patients IT 111

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.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

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.

Medical Student 52

Medical Student Complication Hypertension Utilities 52

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

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;

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

Utilities 64

Utilities Provider Medical IT 64

FDA Law Blog

JUNE 27, 2023

By Véronique Li, Senior Medical Device Regulation Expert & Anne K. 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 ).

Manufacturing 59

Manufacturing Utilities Electronics IT 59

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).

Clinic 64

Clinic Clinical Practice Provider Utilities 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.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. By Adrienne R.

Consulting 52

Consulting Manufacturing Utilities Provider 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.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

FDA Law Blog

MAY 27, 2024

(HPM) proudly announces the return of Jennifer Newberger as a Director, further boosting its already robust medical device practice. 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.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

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)

Referral 40

Referral Hypertension Primary Care Utilities 40

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.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

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 do not provide nor engage in rendering legal, accounting, or other professional services.

Finance 52

Finance Insurance Individual IT 52

FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Provider 69

Provider IT Consulting Utilities 69

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.

Electronics 40

Electronics Physicals Provider Utilities 40

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. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. Dr. Baum was the columnist for American Medical News for more than 25 years.

Patients 52

Patients Private Practice Management Healthcare 52

The Motivated MD

OCTOBER 3, 2024

Many who follow this blog know that I reside in South Carolina. Wiped-out grocery stores, medications unfilled, spoiled food, hours-long lines for gasoline, and impatient citizens pulling firearms on each other, escalating tensions in an already tumultuous time. However, this is a personal finance blog, and for me, it goes beyond that.

Insurance 52

Insurance Finance Community Medical Advice 52

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. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order.

Utilities 52

Utilities Provider Individual IT 52

FDA Law Blog

JUNE 27, 2024

paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. A pharmacist is prohibited “from filling a prescription for a controlled substance when he either knows or has reason to know that the prescription was not written for a legitimate medical purpose.” By Larry K.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

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.

Electronics 59

Electronics Utilities Specialization IT 59

Physician's Practice

JUNE 27, 2025

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. I refer to this thought transference as the Bathroom Experience (BE), a powerful metaphor for how seemingly minor details can dramatically impact patients’ perceptions of a medical practice.

Management 52

Management Private Practice Patients Medical 52

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. §

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

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.

Patients 52

Patients Illness Hospital Management 52

FDA Law Blog

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. That seems very unlikely to be the case, because exemptions apply only to well-established tests.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 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. This blog will discuss what early adopters do to implement innovative and exciting practices.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

APRIL 23, 2023

Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g., If sponsors do not own the data used for the external control arm, they should structure agreements with the data owner to ensure that patient-level data can be provided to FDA.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

FDA Law Blog

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. By Philip Won & Lisa M. The single-use device exception under 21 CFR 801.30(a)(3)

Specialization 45

Specialization Supply Chain Manufacturing Medical 45