FDA Law Blog

MARCH 16, 2023

The inclusion of a requirement to test twice over three days with at least 48 hours between tests is consistent with study findings from the National Institute of Health published in 2022 ( LINK ); however, it is not clear if this proposed use case is practical for “point-of-care” outside of an in-patient setting.

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Healthcare Professional Specialization Transportation Diagnosis 40

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

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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. Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. A comprehensive history includes: A body temperature exceeding 100.4°F

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Diagnosis Management Illness Diagnose 130

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . 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. Right, Katie?

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Illness Patient-Centered IT Patients 103

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. And you wrote, actually, a beautiful GeriPal blog about it a while ago.

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Illness Patient-Centered Screening Clinic 137

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 127

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. My Life, My Story: VA’s healthcare improvements through deliberate storytelling – YouTube. Storytelling Helps Hospital Staff Discover The Person Within The Patient.

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Patient-Centered Illness Healthcare IT 116

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 106

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

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Illness IT Patient-Centered Patients 102

GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Amber: Thank you guys.

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Patient-Centered Patients IT Healthcare 112

GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. Today we’re going to be talking about narrative writing specifically for healthcare professionals.

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IT Patient-Centered Patients Healthcare 96

GeriPal

DECEMBER 19, 2024

A NY Times article titled Should Patients Be Allowed to Die From Anorexia ? That’s how do we treat the mental health needs of patients with serious medical illness? So in those cases, can we adopt an approach to mental health care that centers primarily around quality of life of patients and their families?

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Illness Mental Health IT Patient-Centered 102

FDA Law Blog

JANUARY 18, 2024

FDA noted that clinical studies demonstrate that marijuana produces physical and psychological dependence, and abuse may lead to moderate or low physical dependence depending on frequency and degree of marijuana exposure. HHS conducted a two-part test to determine whether marijuana has a currently accepted medical use in the U.S.

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Medical Physicals IT Healthcare Professional 69

FDA Law Blog

MAY 5, 2024

FDA further noted that clinical studies demonstrate that marijuana produces physical and psychological dependence, and abuse may lead to moderate or low physical dependence depending on frequency and degree of marijuana exposure. FDA/HHS concluded that marijuana does not meet schedule I criteria.

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Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. GeriPal podcast with Linda Fried on frailty.

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Patient-Centered Patients IT Hospital 96

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Bill: Thank you.

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Illness IT Medical Provider 144

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 89

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

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Patient-Centered IT Patients Hospital 120

GeriPal

APRIL 18, 2024

We discuss, among other things: Findings that in several studies AI was rated by patients as more empathetic than human clinicians (not less, that isn’t a typo). I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.”

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IT Electronics Patients Healthcare 140

GeriPal

MARCH 16, 2023

Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. So I felt like over all these years I have learned so much from my patients and from the science, that it should be out there in one place where people can easily access it and help themselves.

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IT Healthcare Professional Healthcare Transportation 106

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.” Basis at 24. NPRM at 44,607. Basis at 7-8; NPRM at 44,614. Basis at 61; NPRM at 44,615. NPRM at 44,617. at 44,617, 44,619.

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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.” I was a clinical ethics fellow at Baylor College of Medicine.

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Patient-Centered IT Patients Consulting 129

GeriPal

APRIL 26, 2024

Who spends the most time with the patient in the infusion center? 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. I was a clinical ethics fellow at Baylor College of Medicine.

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Patient-Centered IT Patients Consulting 121

GeriPal

DECEMBER 12, 2024

Surrogates often either dont know what patients would want, or think they know but are wrong, or make choices that align with their own preferences rather than the patients. The first one is that a lot of patients, particularly the end of life, probably the majority of them, can’t make their own decisions.

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Patient-Centered IT Patients Healthcare 110

FDA Law Blog

JUNE 1, 2025

The Protecting Patients from Deceptive Drug Ads Online Act, co-sponsored with Senator Mike Braun (R-IN), seeks to close regulatory gaps by empowering FDA to issue Warning Letters and impose fines on social media influencers and telehealth companies that promote prescription drugs without proper disclosures of risks and side effects.

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Healthcare Professional Manufacturing Healthcare Utilities 59