FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

Patients 52

Patients Patient-Centered Clinic Community 52

PEMBlog

SEPTEMBER 25, 2024

Niharika Goparaju Pediatric Emergency Medicine Fellow at the University of Texas – Austin | Dell Children’s Medical Center Instagram: @ngoparaj, @atxpemsquad, @dellmedschool, @cat_yee Co-author: Catherine Yee, MD The Case A 12-year-old male with trisomy 21 presents with one week of right eye swelling and three days of clear eye drainage.

Patient-Centered 52

Patient-Centered Diagnosis Management Patients 52

FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. FDA-2022-E-3124 ).

Clinic 59

Clinic IT Provider Patient-Centered 59

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Heather: I do Alex, and I’m so happy to have this song request, it’s called The Eye by Brandi Carlile, which comes from a quite old 2015 album called The Firewatcher’s Daughter. Summary Transcript Summary.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. Tasce: I do. Tasce: Yes.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

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. Storytelling Helps Hospital Staff Discover The Person Within The Patient. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

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. ABIM MOC credit will be offered to subscribers in November, 2024.

Illness 136

Illness Patient-Centered Screening Clinic 136

GeriPal

JUNE 19, 2025

And so when I had decided to socially, medically, and surgically transition, I had to really sit down with members of the department and really did a lot of in services. Jace, welcome to the GeriPal Podcast. Jace 00:37 Thank you so much, Alex and Eric, it’s nice to be here with you. Noelle Marie 01:19 Cyndi Lauper’s True Colors.

Individual 82

Individual Community IT Chronic Condition 82

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

APRIL 13, 2023

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great. All right.

IT 99

IT Community Patient-Centered Medical 99

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

DECEMBER 14, 2023

More recently Sharon Kaufman ‘s book And a Time to Die described the ways in which physicians, nurses, hospital systems, and payment mechanisms influenced the hour and manner of patient’s deaths. This field is not new. Liz: Well, some aspects of this paper around clinical momentum and things around defaults and that sort of thing.

Hospital 125

Hospital IT Patient-Centered Patients 125

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). 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. What’s up with Medical aid in dying in Canada?

Illness 144

Illness IT Medical Provider 144

PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2015 Apr;22(4):441-6. Epub 2015 Mar 16.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

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. Alex: (Singing).

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

DECEMBER 7, 2023

Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. Summary Transcript Summary To my teenagers, climate change is an existential crisis. Ruth, welcome to GeriPal.

Healthcare 129

Healthcare IT Education Community 129

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. First time on the GeriPal podcast, Liz Lilley, who’s a surgeon and faculty in surgery at the Brigham Women’s Hospital and Harvard Medical School.

Families 106

Families Family Patient-Centered Patients 106

Physician's Weekly

JUNE 12, 2025

Centers for Disease Control and Prevention (CDC) database that includes vaccine safety information from millions of patients, according to multiple sources. It led to revocation of the elder Geier’s medical license and disciplinary action for David Geier for practicing medicine without a license. More information The U.S.

Vaccination 52

Vaccination Patient-Centered Government Diagnosis 52

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Malaz: I love it.

Patient-Centered 125

Patient-Centered IT Families Family 125

Common Sense Family Doctor

JUNE 11, 2025

Several past colleagues in the family medicine department at Georgetown recently published an informative scoping review of specialty disrespect in the medical learning environment. A research letter in JAMA Network Open reported that in 2015 and 2020, graduates of U.S. It's well documented that schools that are ranked highly by U.S.

Primary Care 90

Primary Care Community Primary Care Physician Family Medicine 90

Common Sense Family Doctor

MARCH 23, 2025

Please join me and hundreds of medical organizations in standing with AHRQ and preserving its vital contributions to the health of all Americans. ** For the past 30 years, a little-known U.S. Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency.

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52

GeriPal

JANUARY 5, 2023

No matter what your position on medical aid in dying (I’m ambivalent) or abortion (I’m pro-choice), this is a bioethics podcast, and I hope that we can all agree that the ethical issues at stake deserve a critical re-think. Today, medical aid in dying is legal in some 10 states, and illegal in others. . Summary Transcript Summary.

Provider 19

Provider Medical Hospital Patient-Centered 19

Pamela Wible MD

JUNE 19, 2025

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. In order to heal her patients she first had to heal her ailing profession.

Clinic 246

Clinic Nurse Practitioner IT Medical 246

Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52