FDA Law

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.

Clinic 105

Clinic Provider IT Utilities 105

Plum Health

OCTOBER 29, 2024

Key Features of Subscription Primary Care Unlimited Visits : You’re generally not charged per visit, so you don’t have to worry about co-pays each time you see your provider. Direct Access to Your Doctor : Many DPC providers limit their patient load, meaning you get more face-to-face time with your doctor, often with little to no wait time.

Primary Care 52

Primary Care Insurance Telemedicine Healthcare 52

Physician's Weekly

JUNE 11, 2025

Distributing intake throughout the day has been shown to enhance muscle synthesis, and targeting 90 g/day provides 1.2 The second piece is getting folks to be successful at restricting their calories, which works well when nutrition education and behavioral counseling strategies are combined—and even better when provided in a group setting.

Management 52

Management Primary Care Physicals Telehealth 52

Plum Health

MAY 19, 2023

Raquel Orlich treats a Plum Health member Are you a self-employed individual, uninsured, underinsured, or enrolled in a high deductible catastrophic health plan in the Detroit or Royal Oak area? While your insurance covers significant events, DPC takes care of routine healthcare needs affordably.

Primary Care 52

Primary Care Insurance Medical Advice Healthcare 52

Center for Family Medicine (CFM)

JUNE 1, 2025

This is a time when lesbian, gay, bisexual, transgender, and queer people and allies alike unite to support each other, strengthen the community, and celebrate themselves and others with parades and joyous events. 988 provides local call, text, and chat support whenever needed.

Community 52

Community Physicals Family Medicine DO 52

The Motivated MD

OCTOBER 7, 2024

I am heartbroken for the communities affected by this storm and for our fellow healthcare providers who are either dealing with this in their personal lives or having to navigate recovery as part of their careers. The silver lining of a horrific event like this is the incredible humanity we witness in its aftermath. The Motivated M.D.

Medical Advice 52

Medical Advice Community Healthcare Individual 52

FDA Law

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. 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. By Adrienne R.

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Clinic Manufacturing Provider Electronics 105

Aspiring Minority Doctor

APRIL 18, 2021

Every year, thousands of medical school graduates go unmatched. If you’re a 4th year medical student who is unmatched at this point, my advice is the following: Focus on securing a one year preliminary or transitional year position! What if I fail to match into any position?

GP 52

GP Medical Student Insurance General Practitioner 52

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market. We simply cannot.

Finance 52

Finance Individual Management IT 52

Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

Electronics 59

Electronics Manufacturing Provider Medical 59

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. However, I so commonly see individuals inflate their lifestyle by overextending themselves when buying a home.

Finance 52

Finance Insurance IT Individual 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. Release Stress Anxiety can be pathologic, resulting from a physical or mental disorder beyond an individual’s control.

Primary Care Doctor 52

Primary Care Doctor Primary Care Board-Certified Physicals 52

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Manufacturing Hospital Healthcare Medical 81

GeriPal

DECEMBER 2, 2022

So on today’s podcast we invite four brilliant individuals to talk about their perspective on how to change how we as a society and health care system partner with individuals with dementia. We’re going to be talking about things like creative engagement in individuals with dementia. Susan: Yeah, that was me.

Community 101

Community IT Individual Patient-Centered 101

FDA Law

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA.

Government 40

Government Clinic Individual Provider 40

FDA Law

APRIL 23, 2023

The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g.,

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

GeriPal

OCTOBER 13, 2022

Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. That includes many medical specialists, surgical specialists, many specialists and many other disciplines who are on our older adults team. Rasheeda, welcome to GeriPal.

Complication 97

Complication Patient-Centered IT Patients 97

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: Great story.

IT 102

IT Screening Hospital Clinic 102

PEMBlog

OCTOBER 2, 2024

Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting. This measures both acid and non acid reflux events. So you could start that in the emergency department if the symptoms are severe enough, provided that they have primary doctor follow ups.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

FDA Law

FEBRUARY 27, 2024

156(c)(4) states that “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product” (emphasis added). To that end, 35 U.S.C. § 156(c)(4) See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm. 351, 355-56 (1985). l56(d)(1).

Patients 59

Patients IT Provider Individual 59

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). Objective: To determine whether resident-facility language concordance/discordance is associated with the odds of potentially inappropriate prescribing of antipsychotics (PIP-AP) in LTC.

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Patients Provider Individual Hospital 130

Center for Family Medicine

APRIL 7, 2025

Short-term depression following a sad event, such as a death in the family or getting fired from a job, is expected. However, when depression lingers, additional interventions such as medication or therapy may be needed. Some individuals may have angry outbursts or irritability.

Mental Health 52

Mental Health Individual Diagnosis Family Medicine 52

FDA Law

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report. FDA began an initial VMSR pilot program in 2015.

Medical 59

Medical Manufacturing Individual Provider 59

FDA Law

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

Community 114

Community Transportation IT PCP 114

The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) provision in only English +/- Spanish), limitations of medical technology (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law

MARCH 17, 2022

We believe the proposed 2022 guideline provides much needed clarification of CDC’s recommendations for both practitioners and regulators. As CDC notes in the 2022 proposed guideline, the 2016 guideline provided twelve recommendations for primary care clinicians who prescribe opioids for chronic pain in outpatient settings.

Patient-Centered 75

Patient-Centered Clinical Practice Patients Management 75

GeriPal

MARCH 9, 2023

Today we largely focus on reasons for caution, including: We know almost nothing about psychedelics in older adults – only about 1% of patients in published trials were older adults, much less older adults with multiple chronic conditions, multiple medications, and frailty. There is a marked lack of diversity in published trials.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

FEBRUARY 20, 2025

Summary Transcript CME Summary Trauma is a universal experience, and our approach as health care providers to trauma should be universal as well. So there’s an event or a series of events. So there’s an event or a series of events. Kate 04:53 As well as how they cope with that event.

IT 66

IT Patient-Centered Screening Patients 66

GeriPal

OCTOBER 17, 2024

Summary Transcript CME Summary When treating heart failure, how do we distinguish between the expanding list of medications recommended for “Guideline Directed Medical Therapy” (GDMT) and what might be considered runaway polypharmacy? He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories.

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Referral Family Medicine DO Primary Care 40

FDA Law

JUNE 24, 2021

Cato — On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices , which has been several years in the making. In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). By McKenzie E.

Manufacturing 52

Manufacturing Medical Provider IT 52

GeriPal

MAY 25, 2023

Van Scoy who is a pulmonary critical care advance care planning researcher at Penn State Hershey Medical Center in Pennsylvania. I see us measuring choice of a medical durable power of attorney. And then we were like, Well, what is a medical decision? Well, what’s a major medical decision? Eric: And we have L.J

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Community IT Patient-Centered Primary Care 95