FDA Law Blog

NOVEMBER 1, 2023

Counterarguments abound, many of which were detailed in 2015 in a publication by counsel for the American Clinical Laboratory Association ( here ). In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways).

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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IT Education Utilities Patient-Centered 40

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 ).

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Clinic IT Provider Patient-Centered 59

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.

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Patient-Centered Diagnosis Management Patients 52

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.

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IT Patient-Centered Healthcare Illness 106

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: .

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Patient-Centered Illness Healthcare IT 116

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.

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Illness Patient-Centered Screening Clinic 137

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.

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Patient-Centered IT Healthcare Medical 96

GeriPal

JUNE 19, 2025

Eric and I remember him from that time and he’s now at the University of Nevada, Las Vegas, where he is associate professor in the department of social and behavioral health. Jace, welcome to the GeriPal Podcast. Jace 00:37 Thank you so much, Alex and Eric, it’s nice to be here with you. Eric 01:21 Why’d you choose this song?

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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.

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Patient-Centered Hospital Patients IT 133

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.

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Patient-Centered Complication Patients IT 101

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.

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IT Community Patient-Centered Medical 100

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.

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Hospital IT Patient-Centered Patients 126

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.

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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).

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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: And we’re delighted to welcome Sonu Gaind, who is a Chief of psychiatry and professor at the Sunnybrook Health Sciences Center at the University of Toronto.

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Illness IT Medical Provider 144

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.

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Healthcare IT Education Hospital 130

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. Why do this? Guests Kara Bischoff, James Deardorff, and Elizabeth Lilley have no relationships to disclose. Liz 01:04 I do have the song. Is that right, Cara?

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Families Family Patient-Centered Patients 108

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. Centers for Disease Control and Prevention has more on autism and vaccines. Health and Human Services’ look at rising autism rates in the U.S.

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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.

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Patient-Centered IT Families Family 126

Common Sense Family Doctor

JUNE 11, 2025

A research letter in JAMA Network Open reported that in 2015 and 2020, graduates of U.S. At the residency level, federal investments in rural and federally qualified health center (FQHC)-based programs have resulted in significant training expansions in underserved settings. and 3.6%, respectively, in 2008-09 to 14.3% in 2023-24.

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Primary Care Community Primary Care Physician Family Medicine 90

Common Sense Family Doctor

MARCH 23, 2025

Dubbed " the little federal agency that could ," AHRQ has accomplished this feat with a small fraction of the budgets of its higher-profile cousins, the Centers for Disease Control and Prevention and the National Institutes of Health. spends on health care more wisely or efficiently.

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Healthcare Patient-Centered Primary Care Illness 52

Pamela Wible MD

JUNE 19, 2025

In order to heal her patients she first had to heal her ailing profession. An inspiring leader and educator of the next generation of physicians, Doctor Wible has been named one of the 2015 Women Leaders in Medicine and the “Physicians Guardian Angel.” But is it really burnout—or something more serious? I give you Dr. Pamela Wible.

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Clinic Nurse Practitioner IT Medical 246

GeriPal

JANUARY 5, 2023

We start by talking with Robert Brody, an internist who recalls physicians helping patients die during the height of the AIDS epidemic in San Francisco. Robert was first asked by one of his own patients for assistance in dying in 1991, far before aid in dying was legalized in California in 2016. I got it the second time. Okay, good.

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Provider Medical Hospital Patient-Centered 19

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.

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Patient-Centered Hospital Diagnose Medical 52