Physician's Practice

JUNE 26, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Telehealth 52

Telehealth Management Patients Finance 52

Physician's Practice

JUNE 23, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patients Electronics Finance 52

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. Building a Strong Doctor-Patient Relationship: Regular health check-ups also play a vital role in establishing a strong doctor-patient relationship. What are Regular Health Check-ups?

Preventive Care 52

Preventive Care Preventative Care Mental Health Healthcare 52

Physician's Practice

JUNE 25, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

OCTOBER 16, 2022

James has been involved with the approval of many new molecular entities, often for serious and rare diseases, several which utilized the accelerated approval pathway (see examples discussed here and here ).

Utilities 105

Utilities Patients 105

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.

Diagnosis 122

Diagnosis Diagnose Hospital Clinic 122

FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

Vascular Physician

DECEMBER 2, 2020

While bypass surgery is a "real" operation, in many cases it can solve the patients problem for many years or forever, compared to angioplasty and stenting which may need to be repeated frequently to keep the blood flow open. Patients with peripheral artery disease often have a history of limb claudication, which refers to pain with exertion.

Medical Student 52

Medical Student Complication Hypertension Utilities 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.

Lab Testing 52

Lab Testing Medical Patients Mental Health 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.

Patients 52

Patients Illness Hospital Management 52

The Clinical Problem Solvers

FEBRUARY 9, 2020

Objectives Define likelihood ratios and their utility in diagnostic reasoning Identify how likelihood ratios alter the probability of a diagnosis Apply likelihood ratios in clinical reasoning What are likelihood ratios and how do they work? Thus, we empirically treat patients with ascitic fluid that has > 250 neutrophils/mm 3.

Clinic 52

Clinic Diagnosis Hypertension Patients 52

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 ).

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

AUGUST 4, 2022

Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis. Further, “there is little utility in comparing the language of the BIS to that of the AKS.”. The Lesson of this Case.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. Patients that use ESD undergo continuous 24/7 monitoring. Patients are continually monitored for safety. percent of examples.

Medical 111

Medical Clinic Patients IT 111

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. DMC charters have also grown longer and more detailed.

Clinic 105

Clinic Provider IT Utilities 105

Vascular Physician

FEBRUARY 23, 2020

Ultrasound and CTA can also be utilized to evaluate blood flow through vessels and narrowing of arteries. Patients usually complain of worsening pain at night that is only relieved by hanging the affected leg over the side of the bed or with ambulation.

Referral 40

Referral Hypertension Primary Care Utilities 40

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. SCOTUS has until Dec.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

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.” and remote or wearable patient monitoring devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

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

Physician's Practice

JUNE 24, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patients Consulting Finance 52

FDA Law Blog

JUNE 27, 2024

Prescribing Red Flags In the Gulf Med decision, DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” The expert specifically found that: Patient A.R. By Larry K. Gulf Med Pharmacy; Decision and Order, 86 Fed.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

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

Physician's Practice

JUNE 19, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patients Screening Finance 52

Physician's Practice

JUNE 6, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Finance Patients Healthcare 52

Physician's Practice

JUNE 9, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Healthcare Experience Patients Hospital 52

Physician's Practice

JUNE 27, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Private Practice Patients Medical 52

Physician's Practice

JUNE 20, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patient-Centered Appointment Patients 52

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.

Manufacturing 52

Manufacturing Utilities Government Provider 52

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog.

IT 124

IT Hospital Patient-Centered Individual 124

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 Blog

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

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. These clearances are based on short-term (30 day) patient follow up.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

DECEMBER 6, 2024

However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage. The draft guidance also directs sponsors to consider the biological relevance of a particular animal or disease model for pharmacology studies. Stay tuned for the next iteration of the Cliffs Notes to the Cliffs Notes.

Clinic 59

Clinic Provider IT Electronics 59

FDA Law Blog

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).

IT 40

IT Education Utilities Patient-Centered 40

FDA Law Blog

JUNE 22, 2022

It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

Manufacturing 45

Manufacturing Provider Consulting IT 45