OCFM

MAY 31, 2021

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Family Medicine 52

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OCFM

OCTOBER 23, 2020

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Family Medicine 52

Family Medicine DO Primary Care Patient-Centered 52

OCFM

JULY 14, 2021

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Family Medicine 52

Family Medicine DO Primary Care Patient-Centered 52

OCFM

SEPTEMBER 20, 2023

Notice of Privacy Policy

Family Medicine 52

Family Medicine DO Primary Care Patient-Centered 52

Joy in Family Medicine Coaching

FEBRUARY 7, 2025

We often distance ourselves from emotions to stay focused in emergencies or maintain professionalism with patients or in power differential situations in training. Sometimes though our sympathetic response goes on overdrive and we need grounding or centering techniques. Take your own pulse." Line that up for yourself.

IT 130

IT Patient-Centered Physicals Medical Student 130

FDA Law Blog

JULY 17, 2024

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

The Direct Doctors Difference

DECEMBER 8, 2023

A recent article featured on the medical blog, www.Kevinmd.com , highlights some super important reasons as to why you might consider seeing a doctor who is not affiliated with a hospital or large system. In addition, when patients have testing done at in-hospital labs and facilities, the costs are higher than stand-alone centers.

Primary Care 52

Primary Care Primary Care Doctor Hospital Referral 52

PEMBlog

JUNE 26, 2025

Evaluate clinical findings to determine the need for operative intervention versus observation in stable pediatric patients with soft versus hard signs of vascular or aerodigestive injury. Now, you may recall some teaching that you got in medical school or residency where the management was dictated by which zone was injured.

Management 59

Management Transportation Patient-Centered IT 59

ABIM

JUNE 12, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The following is a summary of the spring meeting. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Internal Medicine Government Community 52

OCFM

DECEMBER 7, 2020

Notice of Privacy Policy

Family Medicine 40

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Priority Physicians

JANUARY 20, 2025

But if you’re a patient of a direct primary care (DPC) practice , you don’t need to guess about orthopedic pain management. Unfortunately, traditional care doctors often resort to the two easiest options for patients with joint or back pain: They send the patient for imaging or refer them to a specialist.

Management 52

Management Primary Care Physician Primary Care Patient-Centered 52

FDA Law Blog

MAY 29, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Principal Medical Device Regulatory Expert & Gail H. As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. By Adrienne R.

Manufacturing 102

Manufacturing Patient-Centered Medical Management 102

ABIM

JUNE 17, 2025

She is currently Associate Director of Solid Organ Transplantation and Section Chief of Hepatology at Rush University Medical Center. And it also required a trip to a test center where I spent the entire day. The post The LKA is a practical approach to lifelong learning first appeared on ABIM Blog.

Internal Medicine 40

Internal Medicine Board-Certified Patient-Centered Specialization 40

FDA Law Blog

DECEMBER 4, 2023

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release. The government asserted additional allegations that are outside our scope.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

FEBRUARY 20, 2023

That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information. It permanently bans the company from trafficking-in patient data on several fronts. FDA is building its Digital Health Center of Excellence (DHCE).

Patient-Centered 105

Patient-Centered Telehealth IT Government 105

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Patients 59

Patients Patient-Centered Clinic Medical 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 ).

Patients 52

Patients Clinic Medical Patient-Centered 52

Priority Physicians

JANUARY 27, 2025

Many of us know where our meals come from, have sufficient clothing, enjoy roofs over our heads, access heating and air conditioning, use reliable transportation, and receive effective medications. That’s when professional help and prescribed medications play a vital role. So why is the general population so anxious?

Primary Care Doctor 52

Primary Care Doctor Primary Care Board-Certified Physicals 52

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law Blog

JUNE 3, 2025

Houck We appreciate receiving feedback on our blog posts. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice.

Clinical Practice 59

Clinical Practice Patient-Centered Patients Clinic 59

FDA Law Blog

JULY 7, 2021

Gibbs — In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. The use of GEDs by JRC is subject to extensive regulation by Massachusetts, including the need for a judge to authorize the treatment for any patient.

Medical 52

Medical Patient-Centered Patients IT 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

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. They also both stressed the value of previous DMC experience.

Clinic 105

Clinic Provider IT Utilities 105

FDA Law Blog

DECEMBER 13, 2023

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. It is a significant step forward for rare disease patients whose diseases bring them within the oversight of DRDMG.

Patient-Centered 59

Patient-Centered Medical Patients IT 59

FDA Law Blog

SEPTEMBER 23, 2022

By Ellis Unger, Principal Drug Regulatory Expert — On September 14, 2022, FDA/CDER/Office of New Drugs, in collaboration with the Duke-Margolis Center for Health Policy, hosted a virtual meeting on advancing premarket safety analytics , including sessions on new FDA Medical Queries and standardized presentations of safety data.

Medical 52

Medical IT Patient-Centered Clinic 52

FDA Law Blog

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. While desirable for patients, validation on multiple platforms can lead to challenges.

Clinic 59

Clinic Patient-Centered Medical IT 59

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. SCOTUS has until Dec.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

DECEMBER 22, 2022

The site offering the treatment, the Judge Rotenberg Educational Center, and parents of patients that were treated with an ESD for self-injurious or aggressive behavior filed a Petition for Review in the D.C. Circuit of FDA’s Final Rule banning the ESD specifically for those purposes.

Patient-Centered 114

Patient-Centered Education Government IT 114

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

PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

Families 101

Families Family Hospital Patient-Centered 101

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 125

IT Patient-Centered Hospital Individual 125

FDA Law Blog

NOVEMBER 6, 2024

As the Court explains, an orphan drug may not be the “same drug” as the same active moiety under the Orphan Drug Act and FDA’s longstanding implementing regulations if one is “clinically superior” than the other by way of greater efficacy, greater safety, or major contribution to patient care (“MC-to-PC”).

Clinic 111

Clinic IT Patient-Centered Consulting 111

Priority Physicians

FEBRUARY 3, 2025

Medical scientists have limited knowledge of it. But as more states legalize cannabis — and medical and recreational use increases — research is being conducted rapidly. Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice.

Board-Certified 52

Board-Certified Primary Care Doctor Primary Care Individual 52

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

OCTOBER 14, 2024

California Stem Cell Treatment Center, Inc., At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.

Clinic 59

Clinic Patient-Centered Asthma Patients 59

FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. The end of enforcement discretion The PR proposes to phase out LDT “enforcement discretion” over a period of four years, after which most LDTs will be subject to all applicable medical device regulatory requirements.

Provider 64

Provider Manufacturing IT Medical 64

FDA Law Blog

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. 21 U.S.C. § Last month bipartisan legislation, S.

Patient-Centered 59

Patient-Centered Mental Health Medical Clinic 59