FDA Law Blog

MARCH 7, 2024

Instead, FDA recommended that sponsors “limit the use of a DMC” to clinical studies in which safety concerns may be unusually high, such as studies that compare rates of mortality or major morbidity or involving a potentially fragile or high-risk population, or large, multi-center studies of long duration.

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Clinic Provider IT Utilities 105

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.

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Patient-Centered Patients IT Medical 52

Imperial Center Family Medicine

APRIL 14, 2025

Know Your Baseline Your first cholesterol screening in your 20s or 30s provides a baseline for future test results. Early screening reveals these “silent” health threats that may otherwise go undetected for years until more serious heart issues such as chest pain, heart failure, or events such as heart attacks or strokes arise.

Screening 52

Screening DO Family Medicine Family 52

StorytellERdoc

FEBRUARY 10, 2014

Ideas and stories are gaining clarity in their stew pot, gently being brewed and tenderly stirred by my gaining energy and renewed attention to the complex range of fragile emotions and simple beauties that envelope a typical work day in a busy trauma center. I looked more closely at this patient. Penile discharges, though?

Physicals 100

Physicals ER IT Patient-Centered 100

FDA Law Blog

APRIL 13, 2025

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). Join us as we break down what went wrong this time. What Happened? The problem?

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Provider Healthcare Professional Patient-Centered Clinic 52

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).

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Patient-Centered Telehealth IT Government 105

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. By John W.M. Combination products might be part drug, part device, or part software or hardware.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit.

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Board-Certified Board-Certified Physicians Community Government 40

Priority Physicians

JANUARY 27, 2025

In fact, for people who’ve experienced terrifying or anxiety-inducing events, therapists apply eye movement desensitization and reprocessing, or EMDR, a technique that mimics the patient’s REM-sleep eye movements, allowing them to “relive” and discuss the incident with decreased anxiety.) Consider us your lighthouse.

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Primary Care Doctor Primary Care Board-Certified Physicals 52

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

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

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 Clinic 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. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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Patient-Centered Clinic Patients Provider 49

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

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.

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Complication Patient-Centered IT Patients 97

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. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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Clinic Relationship Provider IT 64

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

FDA Law Blog

NOVEMBER 1, 2023

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

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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. Gastroesophageal reflux disease is when the patients have severe symptoms that persist and cause long term issues.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

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. So often patients or their caregivers, to be honest with you, are asking for a simple solution. Welcome to the GeriPal podcast, Brienne.

Illness 85

Illness IT Medical Clinic 85

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 Patients 108

Center for Family Medicine

JUNE 13, 2025

A primary care physician ( PCP ) can help identify potential health problems and risks, provide preventative measures, and recommend the right screenings or treatments. The gradual buildup of plaque in the arteries often goes unnoticed until a major event occurs.

PCP 52

PCP PCP Diabetes Primary Care Physician 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. Understand how engaged community-based work, centered on trust and accountability, has supported the health of communities served by Oakland, CA’s Asian Health Service.

Community 52

Community Patient-Centered Relationship Healthcare 52

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. And yet, after assisting the older adult to their feet, the EMS providers would leave.

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Community Transportation IT PCP 115

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 We believe the proposed 2022 guideline provides much needed clarification of CDC’s recommendations for both practitioners and regulators. By Larry K.

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Patient-Centered Clinical Practice Patients Individual 75

GeriPal

MARCH 9, 2023

Early data on efficacy in patients with anxiety and demoralization are promising. Two of our guests today, Stacy Fischer and Brian Anderson, are involved in large multicenter trials of psychedelics for patients with advanced cancer (Fischer) or life-limiting illness (Anderson). Research is exploding. Welcome back to GeriPal, Stacy.

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Patient-Centered Community IT Medical 91

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. AMA PRA Category 1 credit(s) ™.

Patient-Centered 109

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

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.

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IT Patient-Centered Individual Patients 67

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.

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IT Patient-Centered Patients Board-Certified 97

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care.

Family Medicine 40

Family Medicine DO Families Family 40

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

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? Matthew, I get the lyrics.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

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). Hillary: So great to be here. Eric: And we have L.J Welcome to the GeriPal podcast.

Community 96

Community IT Patient-Centered Primary Care 96

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 observed multiple fascinating procedures and patient interactions throughout the externship, and I am grateful to have had the opportunity to glimpse the day-to-day of this field.

Medical Student 40

Medical Student DO Family Medicine Patient-Centered 40

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?

Patient-Centered 117

Patient-Centered Hospital IT Illness 117

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. Rasheeda, welcome to GeriPal.

Complication 52

Complication Patient-Centered IT Patients 52