FDA Law Blog

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinic Provider IT Utilities 105

Physician's Weekly

JUNE 16, 2025

from MedStar Union Memorial Hospital in Baltimore, and colleagues retrospectively identified and evaluated 130 ankles from 122 patients with a mean follow-up of 5.9 years after primary TAA to examine implant survivorship and clinical and radiographic outcomes. percent) had adverse events, with medial gutter debridement (22 ankles; 16.9

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Patient-Centered Hospital Physicals Clinic 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

ABIM

JUNE 12, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. For example, in specialties like cardiovascular disease and medical oncology with prevalent geriatric patient populations, concepts like frailty and falls may not be covered in assessment materials.

Board-Certified 52

Board-Certified Internal Medicine Government Community 52

GeriPal

JANUARY 23, 2025

Today, we explore four fascinating studies highlighting innovative approaches to reducing medication use and improving patient outcomes. Patients received brochures detailing the risks of gabapentinoids, nonpharmacologic alternatives, and a proposed deprescribing regimen (see here for the brochure ). in the usual care group.

Specialization 119

Specialization IT Patient-Centered Medical 119

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

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

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Manufacturing Patient-Centered Provider Telehealth 59

GeriPal

OCTOBER 13, 2022

When I’m on service these days there is inevitably a moment when a resident says “Patient so-and-so is on X” – and I have absolutely no idea what X is. Alex: And we are delighted to welcome Rasheeda Hall, who is a physician scientist in the division of nephrology at Duke University School of Medicine, and sees patients at the Durham VA.

Complication 97

Complication Patient-Centered IT Patients 97

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dave noted the Diplomate Professional Profile’s potential outside of Specialty Board discussions with data that could be valuable to patients with specific needs and conditions.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. &

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. stroke).

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Patient-Centered Clinic Patients Provider 49

FDA Law Blog

JANUARY 12, 2025

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

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Clinic Relationship Provider IT 64

FDA Law Blog

APRIL 13, 2025

LYTGOBI was granted accelerated approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or rearrangements. Join us as we break down what went wrong this time. What Happened? The problem? As a single-arm trial (i.e.,

Provider 52

Provider Healthcare Professional Patient-Centered Clinic 52

GeriPal

DECEMBER 2, 2022

She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. You wrote about how when it comes to talking about patients with dementia, they’re rarely portrayed as resilient. And the person with dementia, the patient, said yes. How do we move on?

Community 101

Community IT Individual Patient-Centered 101

GeriPal

JULY 27, 2023

Alex: And we have Cathy Alessi, who is a geriatrician, Director of the Geriatrics Research Education and Clinical Care Center at the VA, greater Los Angeles and Professor of Medicine at UCLA. Sleep is a focus of your academic and clinical career. Welcome to the GeriPal podcast, Brienne. Brienne: Thank you for having me.

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Illness IT Medical Clinic 85

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Physician's Weekly

JUNE 14, 2025

The following is a summary of “ORAKLE: Optimal Risk prediction for mAke30 in patients with sepsis associated AKI using deep LEarning,” published in the May 2025 issue of Critical Care by Oh et al.

Patient-Centered 52

Patient-Centered Patients Individual Clinic 52

The Clinical Problem Solvers

DECEMBER 20, 2021

[link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Early data on efficacy in patients with anxiety and demoralization are promising. She’s also a leader in the Cancer Prevention and Control Center at the University of Colorado there at the Cancer Center.

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Patient-Centered Community IT Medical 91

FDA Law Blog

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. CDC Clinical Practice Guideline, 10. By Larry K. 7,838 (Feb.

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Patient-Centered Clinical Practice Patients Management 75

FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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Provider Patient-Centered Clinic Clinical Practice 108

GeriPal

JULY 11, 2024

It’s a jampacked 50 minutes, filled with pearls on taking care of patients with liver disease. Kirsten 04:16 So, in emergency medicine, obviously, we are interacting and caring for these both exciting and interesting, but also very complex and humbling patients to care for in the ED setting. What’s the connection and why?

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Patient-Centered IT Patients Clinic 109

GeriPal

NOVEMBER 7, 2024

If the purpose of initiating dialysis is improving function – our complex, frail, older patients are likely to be disappointed. Are we seeing people like more older adults, more nursing home patients starting dialysis, and even at a higher gfr? So I wonder if I could turn to either of our nephrologists.

Management 116

Management Patient-Centered Patients IT 116

GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. So there’s an event or a series of events.

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IT Patient-Centered Screening Patients 66

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. Going into patient’s homes was eye opening. It was eyeopening to see patients in their own home. And so that really triggered my interest.

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Community Transportation IT PCP 114

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. When I see a patient? He’s in Boston.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

GeriPal

MAY 22, 2025

Jenny Chen is a palliative care fellow at Yale who regularly sings for her seriously ill patients. Jenny reached out to us because she plays music regularly for her patients, and she said, you should do a podcast about music. And I performed for many palliative patients, and that’s when I started to understand.

IT 96

IT Patient-Centered Patients Board-Certified 96

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? Alex: And we are delighted to welcome Rasheeda Hall, who is a physician scientist in the division of nephrology at Duke University School of Medicine, and sees patients at the Durham VA.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

MAY 25, 2023

Others cited the call from communities to meet them where they are – be they senior centers, Black-owned businesses, or churches (we have a podcast planned in the fall with Fayron Epps and Karen Moss on the church setting). So am I measuring it for that specific clinic level quality metric or am I measuring it for my research study?

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Community IT Patient-Centered Primary Care 95

GeriPal

OCTOBER 26, 2023

Summary Transcript Summary Often podcasts meet clinical reality. But rarely does the podcast and clinical reality meet in the same day. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility. Dear listeners, if you have a podcast idea, feel free to reach out to us.

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Patient-Centered Hospital Patients IT 132

Aspiring Minority Doctor

DECEMBER 31, 2024

In February, I decided to see what the hype was about, so on a weekend I wasn't on call, I worked all day Friday, came home around 8pm and went to bed, woke up after midnight, got dressed and made it to the club at 2am and got to see Jeezy perform front in center. I had definitely been missing out!

Medical Student 52

Medical Student IT Patient-Centered Medical 52

Maine Academy of Family Physicians

OCTOBER 22, 2023

Der Simonian at the Falmouth Family Medicine office and at the Maine Medical Center Mother Baby Unit. I also spent one day at the Maine Family Planning clinic in Augusta, shadowing the head clinician, Lindsey Piper, NP. At the Family Medicine office, I observed the close relationships fostered between Dr. Der Simonian and her patients.

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Medical Student Family Medicine DO Patient-Centered 40

GeriPal

AUGUST 17, 2023

Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”.

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Patient-Centered IT Clinic Patients 98

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 IT Patients 133

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. Clinicians were randomized to 4 groups: Usual care Prognosis nudge – EHR prompt asking, do you think your patient will be alive in 6 months?

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Patient-Centered Hospital IT Illness 116