FDA Law Blog

MARCH 16, 2023

The new regulation is listed as 21 CFR 866.3982: “Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings.” The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.

Healthcare Professional 40

Healthcare Professional Specialization Diagnosis Transportation 40

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). Mirati) about a healthcare professional branded website for KRAZATI (adagrasib).

Provider 52

Provider Healthcare Professional Patient-Centered Clinic 52

Rao Doctor

APRIL 3, 2025

Infrared thermometers, which measure temperature from the forehead or ear, are also prevalent in clinical settings. Mayo Clinic : Mayo Clinic’s website provides a rich repository of medical literature detailing different types of fever, their symptoms, and treatment options. And I do this regularly.

Diagnosis 130

Diagnosis Management Illness Diagnose 130

GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

IT 126

IT Patient-Centered Illness Education 126

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. ABIM MOC credit will be offered to subscribers in November, 2024. Who do we have with us today?

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. It’s been around for a long time but is acting like the hot new kid in town. But does this drug really live up to the hype? Right, Katie?

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

DECEMBER 8, 2022

My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Eric’s blog post on Dignity Therapy from 2011. Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? Because that really is what this is about. Wonderful work.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

SEPTEMBER 22, 2022

And I think also some of the stuff we’ll be talking about, when it comes to communication, I mean, a lot of the clinical encounter is listening to the music. Coming off as rote and scripted during a serious illness conversation can have a similar off-putting impact on patients and families. Key message: Listen to the music. All right.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

MARCH 30, 2023

Today we’re going to be talking about narrative writing specifically for healthcare professionals. My entree into healthcare is not in the academic space at all. I started blogging as a patient, just talking about my own story online like patients did back in the day. So unlike academic journals and elsewhere.

IT 95

IT Patient-Centered Patients Healthcare 95

FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. 21 U.S.C. §

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

FEBRUARY 9, 2023

Amber tells the moving story of how these findings led a clinical colleague, her chief, to question and change his behavior. As we’ve written about on GeriPal when we were a blog (a decade ago!) Amber: Well, simulation is pretending, so I think of the way I use simulation is in trying to simulate clinical care. Amber: I do.

Patient-Centered 111

Patient-Centered Patients IT Healthcare 111

GeriPal

JANUARY 11, 2024

Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. To many this rapid expansion will represent autonomy run amok. It was amazing.

Illness 144

Illness IT Medical Provider 144

GeriPal

DECEMBER 19, 2024

We invited Dani Chammas , a palliative care physician and psychiatrist at UCSF (and a frequent guest to the GeriPal podcast), as well as Brent Kious , a psychiatrist at the Huntsman Mental Health Institute, focusing on the management of severe persistent mental illnesses. What does it look like to take a palliative approach to severe mental illness?

Illness 101

Illness Mental Health IT Patient-Centered 101

FDA Law Blog

MAY 5, 2024

Letter to DEA Administrator Anne Milgram, from Assistant Secretary for Health Rachel Levine (Aug. 29, 2023). By recommending rescheduling to schedule III, FDA/HHS determined that marijuana no longer meets schedule I criteria under the CSA and that it does not meet schedule II criteria either. Letter to U.S. 21 U.S.C. § 812(b)(1).

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

MARCH 3, 2022

Alex: And we’re delighted to welcome you to the GeriPal Podcast, Julien Cobert, who is an intensivist and aging researcher GeriPal Podcast, Julien. Julien: Thanks Alex, thanks Eric. It’s great to be here. Eric: So we’re going to be talking about aging in the ICU. Chris Cornell is one of my favorite musicians. Alex: (Singing).

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

MARCH 20, 2025

Alex 00:48 And we’re delighted to welcome back Josh Briscoe, who’s a palliative care doc at the Durham VA Medical center in Duke and blogs at Notes from a Family Meeting. I was part of a writing group that wrote clinical guidelines for VSET for voluntarily stopping eating and drinking. Hope Wechkin brought this topic to us.

IT 87

IT Patient-Centered Patients Medical 87

GeriPal

MARCH 16, 2023

How do you find time to write and also be doctors and academic professors? Revisions and working with editors Writing an Op Ed – how to start, what to write, where to send it TheOpEdProject as a resource for learning more We look forward to the books and op-eds our listeners will write! Welcome to the GeriPal podcast, Rosanne.

IT 105

IT Healthcare Professional Healthcare Transportation 105

GeriPal

APRIL 18, 2024

Skepticism on the ability of predictive models to transform healthcare Consolidation of EHR’s into the hands of a very few companies, and potential for the drug and device industry to influence care delivery by tweaking AI in ways that are not transparent and already a sort of magical black box. Eric: What song are you going to play, Bob?

IT 139

IT Electronics Patients Healthcare 139

GeriPal

SEPTEMBER 19, 2024

Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Give too little – it may not work. This is Eric Widera. Alex This is Alex Smith Eric A nd Alex, who do we have with us today? Jennifer 01:20 I do have a song request for Alex. I think it was Emily.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

FDA Law Blog

MAY 21, 2024

DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § NPRM at 44,619. NPRM at 44,601.

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” What about ambivalence on the part of the provider?

Patient-Centered 128

Patient-Centered IT Patients Consulting 128

GeriPal

APRIL 26, 2024

Alex: We are delighted to welcome Bryanna Moore, who is a philosopher and bioethicist, and she’s at the University of Texas Medical Branch where she also directs the clinical Ethics Fellowship. He is a palliative care physician at the Durham VA Medical Center in Duke and blogs on Substack at Notes from a Family Meeting.

Patient-Centered 119

Patient-Centered IT Patients Consulting 119

GeriPal

DECEMBER 12, 2024

Butstay with us heremight AI help to address some of the major issues present in surrogate decision making? Or does it raise more issues than it solves? Algorithms using millions of direct observations of a persons behavior to provide an authentic portrait of the way a person lived? Alex and I don’t make anything on it. Not always anyway.

Patient-Centered 108

Patient-Centered IT Patients Healthcare 108

FDA Law Blog

JUNE 1, 2025

This year is shaping up a bit differently with all four OPDP enforcement letters addressing healthcare professional materials (including a speaker slide deck!!). Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization. Healthier populations are more productive.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59