FDA Law Blog

JULY 17, 2024

We also commend and congratulate the legions of rare disease patient advocates and the leadership of the EveryLife Foundation for Rare Diseases (“ELF”) who championed the advocacy efforts that led to this important milestone. By Sarah Wicks & James E. Valentine & Frank J.

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Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

APRIL 25, 2023

Users of eSTAR templates need to add attachments for cybersecurity risk management, cybersecurity management plan, continuing support plan, and cybersecurity labeling. Special 510(k)s. This example suggests that the prospects are poor for adding cyber features via a Special 510(k). 510(k) exempt.

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Specialization Provider Medical Manufacturing 105

PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management.

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Patients Complication Management Consulting 52

The Motivated MD

OCTOBER 10, 2024

With increasing emphasis on patient turnover and documentation, all while navigating the complexities of billing and authorization, our jobs are stressful and time-consuming. Here are a few reasons: Overwhelmingly, index funds have lower expense ratios because they are passively managed. Most clinical physicians are busy.

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Finance Individual Management IT 52

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We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: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

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

Physician's Weekly

JUNE 19, 2025

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

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Nurse Practitioner Families Family Primary Care 52

FDA Law Blog

JUNE 10, 2024

The hospital also “entered into a Memorandum of Agreement with the DEA requiring Palomar Health to undertake additional measures to increase security, implement specialized training, and to handle controlled substances properly and safely.” DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ).

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Management Patient-Centered Hospital Healthcare 59

Medical Xpress

JUNE 16, 2025

A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session. Ibogaine shows potential for promoting neuroplasticity and aiding recovery, though it carries cardiac risks that require careful management.

Mental Health 52

Mental Health IT Medical Specialization 52

ABIM

JUNE 4, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) or Canada to become eligible for ABIM Board Certification.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

GeriPal

JANUARY 25, 2024

He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. ABIM MOC credit will be offered to subscribers in November, 2024. Your research is a lot in this patient population, right? The article we discuss today, also published in JAMA , addresses these two gaps.

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Patient-Centered IT Illness Patients 122

GeriPal

JULY 11, 2024

It’s a jampacked 50 minutes, filled with pearls on taking care of patients with liver disease. ABIM MOC credit will be offered to subscribers in November, 2024. And, you know, I just thought it was a really special song. Widera and Smith have no relationships to disclose. For any MOC questions, please email moc@ucsf.edu.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam.

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

JUNE 13, 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.

Illness 133

Illness Patient-Centered Patients IT 133

PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Updated February 26, 2024.

Complication 52

Complication Patient-Centered Management Patients 52

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

JUNE 5, 2025

Despite these substantial needs, specialized palliative care beyond hospice is rare in nursing homes. How to think about primary and specialized palliative care in this setting. JAGS 2024 Nursing Home Palliative Care Referral Process, Barriers, and Proposed Solutions: A Qualitative Study. Alex 03:21 Beautiful, beautiful song.

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Nurse Practitioner Referral Consulting Board-Certified 78

GeriPal

FEBRUARY 29, 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. Alex: Okay.

IT 126

IT Patient-Centered Illness Education 126

PEMBlog

JULY 10, 2024

Listen Emily Labudde & Brad Sobolewski “Syphilis” PEM Currents: The Pediatric Emergency Medicine Podcast, July 10, 2024 [link] Subscribe Apple Podcasts Spotify YouTube References Emily J. Labudde, Jane Lee; A Review of Syphilis Infection in Pediatric Patients. July 2024; 45 (7): 373–380. Pediatr Rev.

Patient-Centered 52

Patient-Centered Patients IT Physicals 52

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Consulting Individual Families Family 59

GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. ABIM MOC credit will be offered to subscribers in November, 2024. I think even the word patient, patient, I think, comes from the word suffer, the one who suffers. 2023 Dec 20:S1524-9042(23)00202-3. doi: 10.1016/j.pmn.2023.11.004.

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IT Families Family Physicals 137

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. It meets in-person, once a month, over nine sessions. This is Eric Widera.

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IT Patient-Centered Families Family 99

GeriPal

MARCH 20, 2025

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

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IT Patient-Centered Patients Medical 87

GeriPal

AUGUST 1, 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. Go on, Anna.

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IT Diabetes Chronic Disease Patient-Centered 116

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. ABIM MOC credit will be offered to subscribers in November, 2024. Eric 00:13 And Alex, we have a super special today, three different articles.

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Families Family Patient-Centered Patients 106

GeriPal

MARCH 27, 2025

Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). And interesting enough, this is a really fascinating study that just got published in JAMA I M in December of 2024. Alex 03:54 Very generous. Is that right?

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Primary Care IT Clinic Patient-Centered 79

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Care Ecosystem.

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Patient-Centered IT Families Family 125

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

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Hospital Patient-Centered Supply Chain IT 115

PEMBlog

MAY 9, 2024

Updated 2024 Jan 19]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. 2024 Feb 11:S0196-0644(24)00017-9. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. How do we evaluate and manage them? Febrile Seizure.

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Illness Vaccination Families Family 59