PEMBlog

SEPTEMBER 26, 2024

This case was submitted by Dr. Inbar Plaut PEM Fellow at UMASS Chan Medical School | UMASS Memorial Children’s Medical Center IG handle(s): @inbar.y, @umasspem Co-author: Zachary Binder The Case A 2-month-old male presents with 2-days of reluctance to move the right lower extremity. This is the last of the four cases. Osteomyelitis D.

Routine Screenings 59

Routine Screenings Patient-Centered Diagnosis Clinic 59

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Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). While the first topic is addressed primarily in the December 2024 draft guidance, the considerations and policies FDA articulates in the January 2025 draft guidance are also relevant.

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IT Clinic Provider Patients 105

The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  Accessed 2024. Ring the Alarm.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

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Provider Medical Manufacturing Consulting 59

Today's Hospitalist

MAY 9, 2025

But these early systems often struggled with complex medical terminology and the natural flow of conversation. For many of us, the emergence of medical scribes, both in-person and remote, provided a valuable solution, offloading documentation and allowing us to have more focused patient interactions. Dragon Medical One.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

Priority Physicians

JANUARY 20, 2025

Consider a patient with painful arthritic knees who has tried several oral medications without experiencing relief. Maybe they think it’s time to consult an orthopedic surgeon for immediate joint replacement. Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice.

Management 52

Management Primary Care Physician Primary Care Patient-Centered 52

The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  Accessed 2024. Ring the Alarm.

Mental Health 52

Mental Health Community Hospital Appointment 52

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

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Clinic Provider Consulting Medical 69

FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. KP Medical Device Consulting LLC

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Consulting Medical Management Specialization 52

FDA Law Blog

MARCH 3, 2024

3558 ) on January 25, 2024. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” Gonzalez & JP Ellison — The most recent version of the BIOSECURE Act (the “Act”) was introduced in the U.S. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law Blog

APRIL 22, 2024

Milgram’s predecessors, and Directors of National Drug Policy urging not to reschedule; the January 2004 letter Democratic state attorneys general pushing for rescheduling to schedule III; and the January 2024 letter from Democratic senators requesting descheduling altogether. The senators write that the U.S. Whether DEA believes the U.S.

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Manufacturing Consulting IT Individual 59

FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. As an example, we filed a 513(g) request in December 2024. If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA.

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Provider IT Consulting Utilities 69

PEMBlog

MAY 20, 2025

2024-066854. 2024-066855. Do you think that medical-legal concerns also play a role? I think medical-legal implications do play a role, and there’s been studies on that, but it’s mostly in the general EM literature, not as much in pediatrics. Pediatrics. 2024;154(1):e2024066854. doi:10.1542/peds.2024-066854.

Family 101

Family Families Hospital Patient-Centered 101

FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance.

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Clinic Relationship Provider IT 64

FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

Provider 59

Provider IT Consulting Medical 59

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. If FDA accepts the application, the sponsor can then submit their supplement in two parts.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. Coconut Grove Pharmacy; Decision and Order, 89 Fed. For these, the expert found that Patient J.C. 21 C.F.R. §§ 1306.04(a), a), 1306.06. 72,694 at 72,694. at § 64B16-27.810(2).

Insurance 52

Insurance Patients Utilities Chronic Condition 52

Annals of Family Medicine

NOVEMBER 20, 2024

Addiction medicine consult services have emerged to help address the shortage in access to SUD treatment. This intervention used a primary care addiction consultation service model including education, an addiction medicine consultant, and practice facilitation to increase capacity for opioid use disorder (OUD) treatment.

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Primary Care Consulting Medical Illness 130

Today's Hospitalist

JUNE 7, 2025

Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. These medications are truly life-changing for many patients.” Nor should they be.

Hospital 66

Hospital Management Diabetes Patients 66

GeriPal

FEBRUARY 2, 2024

This week, we talk about the other major palliative care trial of default palliative care consults for hospitalized older adults with COPD, kidney disease, or dementia, published in the same issue of JAMA. and consulting for Papa Health. ABIM MOC credit will be offered to subscribers in November, 2024. laughter] Alex: Yeah.

Consulting 120

Consulting Hospital Patient-Centered IT 120

Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. According to a 2024 survey , of the roughly 431,000 licensed nurse practitioners, 15% are, like Johnson, certified to treat older adults.

Nurse Practitioner 52

Nurse Practitioner Family Families Primary Care 52

FDA Law Blog

JUNE 30, 2024

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape. To register visit the official conference website, here. Lenz Adrienne R.

Medical 52

Medical Consulting Manufacturing Provider 52

PEMBlog

JUNE 2, 2025

While elevated blood pressure readings are critical data points, the presence of symptoms and signs of end-organ dysfunction are paramount in diagnosing a hypertensive emergency (Kamat 2024). 3 mg/kg/hr; onset of action is less than 5 minutes, and the duration of medication lasts between 2-6 hours. Labetalol dosing: 0.2-1

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Hypertension Management Physicals Lab Testing 75

ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

GeriPal

JANUARY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

FDA Law Blog

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The final rule will be effective on September 10, 2024.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

GeriPal

JUNE 5, 2025

JAGS 2024 Nursing Home Palliative Care Referral Process, Barriers, and Proposed Solutions: A Qualitative Study. And assisted living doesn’t offer the same level of medical supportive services as nursing homes. And so we do have consultants who come in the building. And usually it’s simply for a consultation.

Nurse Practitioner 78

Nurse Practitioner Referral Consulting Board-Certified 78

GeriPal

APRIL 4, 2024

Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024. ABIM MOC credit will be offered to subscribers in November, 2024. And the classic case that we often hear of is the poor old person who got a whole lot of medical treatment they wouldn’t have wanted an ICU flog.

Family 112

Family Families Patient-Centered IT 112

GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions.

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Brad’s not a pediatric medical geneticist.

Consulting 59

Consulting Individual Family Families 59

FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. ABIM MOC credit will be offered to subscribers in November, 2024. What’s up with Medical aid in dying in Canada?

Illness 144

Illness IT Medical Provider 144

GeriPal

FEBRUARY 15, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Community Transportation IT PCP 114

FDA Law Blog

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Clinic Provider Individual IT 59

PEMBlog

JANUARY 16, 2025

Updated February 26, 2024. Its evolved from its medical and industrial applications to a recreational substance with a significant cultural footprint. I would consult a toxicologist because I know that this is rare. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients.

Complication 52

Complication Patient-Centered Management IT 52

GeriPal

JANUARY 18, 2024

Lastly, we discuss Katie’s paper on substance use disorder in an aging population and how one can incorporate the 5 Ms (ie, matters most, medications, mind, mobility, and multicomplexity) into a framework for age-friendly care for older adults with substance use disorder. ABIM MOC credit will be offered to subscribers in November, 2024.

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

NOVEMBER 21, 2024

It’s amazing how often when we’re taking care of somebody in the hospital, if you have Say, you know, a family member who is not showing up for visits with the medical team or who is. It’s not in the capacities of what we can do medically. And what, you know, medical practice assessment precedes plan.

Illness 125

Illness IT Patient-Centered Patients 125