FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. He has written ten books on practice management and the business of medicine.

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Patients Private Practice Management Healthcare 52

Physician's Practice

JUNE 26, 2025

Reynolds Feature Video Introducing Neil Baum, MD, Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana, and the author of multiple books. Have you ever wondered who is giving all the advice on Physicians Practice ? Our goal is to humanize expertise while adding fresh energy to your practice.

Management 52

Management Diabetes Patients Insurance 52

GeriPal

MARCH 14, 2024

Nicole: Yeah, I think definitely delirium, but there are also a lot of medical conditions that can be specific to hospitalizations. Are medications part of that, too? So, a lot of medications, you can see the secondary effects of dysphagia causing those, as well. We’ll also look at cognitive status, medications.

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Hospital IT Patient-Centered Individual 124

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not.

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IT Screening Hospital Clinic 102

GeriPal

JULY 19, 2024

There’s an article about her in New York Times. Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. We didn’t have medications that were effective with a few side effects.

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Screening Primary Care Patient-Centered IT 119

GeriPal

JANUARY 12, 2023

If you want to do a deeper dive in ACE units, check out some of the following articles: The original NEJM paper on ACE units from 1996. Alex: And we’re delighted to welcome back to the GeriPal Podcast, Stephanie Rogers, who’s a geriatrician and medical director of UCSF’s, age-friendly health systems. Great to be here.

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Hospital Patient-Centered IT Nurse Practitioner 100

Physician's Weekly

JUNE 22, 2025

High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice. 10.2]) and cost-related medication non-adherence (OR, 11.8 [2.7-52.1]),

Healthcare 52

Healthcare Transportation IT Insurance 52

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Brian: For the use of substances like psilocybin and LSD in medical care, or at least in investigational treatments, I like to call it psychedelic therapy. Are we talking about hallucinogenics? Eric: Yeah.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

SEPTEMBER 1, 2022

Alex: We are honored to be joined by Barbara Jones, who is professor and associate dean for Health Affairs at the School of Social Work at UT Austin and chair of the Department of Health Social Work at Dell Medical School. So in preparation for this, I read a couple articles about social work leadership in palliative care.

IT 102

IT Family Families Clinic 102

GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. We got a couple of articles to discuss and a lot of different components of this.

Illness 136

Illness Patient-Centered Screening Clinic 136

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

Patients 72

Patients Clinic Patient-Centered Illness 72

GeriPal

FEBRUARY 6, 2025

We have two new FDA-approved medications that reduce that amyloid buildup and modestly slow down the progression of the disease. He is associate professor at the University of Wisconsin and medical director of their Alzheimer’s Disease Research Center. What is the role of the amyloid antibody treatments? Great to be back.

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Primary Care Diagnosis Screening IT 95

GeriPal

APRIL 4, 2024

In case you miss the introductions at the start of the podcast, Bernie and Laurie are married, and offer wonderful reminiscence of their clinical practice over the last several decades. You write about this, you’ve written this New England Journal article, you’ve written past articles.

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Family Families Patient-Centered IT 112

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’m not sure if you read that article and whether or not it’s changed your mind or whether or not you want to do any more research in advance care planning. Welcome to the GeriPal podcast.

Community 95

Community IT Patient-Centered Primary Care 95

GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers. It came after engaging her.

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IT Community Patient-Centered Medical 99

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.

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IT Patient-Centered Illness Education 126

GeriPal

OCTOBER 19, 2023

Additional links mentioned in the podcast: Recent JGIM article on POLST in California nursing homes, hospitalization, and nursing home care Karl’s GeriPal post on appropriate use of POLST Enjoy! So now it’s just POLST, the word POLST, Portable Medical Orders. Respectful disagreement is in short supply these days. Good to know.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

GeriPal

AUGUST 24, 2023

Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. Medical Assistance in Dying and Palliative Care: Shared Trajectories Transcript Eric: Welcome to the GeriPal Podcast. And we published in the Journal of the American Medical Association.

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Patient-Centered Patients IT Illness 98

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. We discuss an article they wrote about PULET for the American Journal of Hospice and Palliative Medicine, including: What makes a PULET a PULET? Ivermectin to treat cancer.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

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. Alex 19:12 And what’s the clinical takeaway from that?

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Patient-Centered IT Screening Individual 66

GeriPal

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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IT Patient-Centered Patients Medical 87

GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. Ruth: I do have to also say that it’s important to remember that feeding tube use and hospital transfers for people with advanced dementia has no demonstrated clinical benefit. And to keep it short work for an article.

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Nurse Practitioner Hospital Family Families 60

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. But before we dive into the study and the implications it has for the practice that we do, I believe someone has a song request. We did it by the clinic level. Jasmine, is it you?

Primary Care 79

Primary Care IT Clinic Illness 79

GeriPal

JULY 13, 2023

[laughter] Bob: That’s what happens when junior faculty get invited on the podcast [laughter] Eric: So we’re going to be talking about the article that just came out in JAMA on a priming intervention for goals of care conversations in hospitalized patients with serious illness. We’ll have a link to the article on our notes.

Patient-Centered 83

Patient-Centered IT Hospital Patients 83

GeriPal

JUNE 6, 2024

Sharon Bober, clinical psychologist at DFCI, notes that clinicians can get caught in an anxiety cycle, in which they are afraid to ask, don’t ask, then have increased anxiety about not asking. And it actually came up during a clinical encounter that I had. Clearly this issue is important to patients. Sharon, welcome to Jerry Powell.

Illness 130

Illness IT Physicals Patients 130

GeriPal

DECEMBER 1, 2023

Summary Transcript Summary There is a growing push to change how we define Alzheimer’s disease from what was historically a clinically defined syndrome to a newer biological definition based on the presence of positive amyloid biomarkers. So too systolic hypertension in elderly people, clinical trials. Alex: That’s right.

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IT Clinic Illness Hypertension 115