FDA Law Blog

FEBRUARY 29, 2024

FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. While that’s quite a while ago, the file was complicated by a fight over the IRTNMTA (see our previous post here ).

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

AUGUST 11, 2024

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions.

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Clinic Provider IT Complication 59

Physician's Weekly

JUNE 19, 2025

Frail patients often have compromised immune responses, which increases their vulnerability to infections and reduces their ability to recover from acute respiratory illnesses (ARIs), including influenza and respiratory syncytial virus (RSV), the researchers continued. Data came from the three influenza seasons from 2012 to 2015.

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Illness Hospital Patients Management 52

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? Samir: For me, it really came out of an interest in improving the care of patients who undergo surgery. AlexSmithMD.

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Patient-Centered Complication Patients IT 101

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

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. We discuss the moral distress that clinicians felt including, as one physician put it, a sense of your soul being ripped out.

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Hospital IT Patient-Centered Patients 126

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

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Families Family IT Patients 107

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. So we’re going to be talking about this complicated topic that a lot of people have differing opinions to and potentially very strong opinions, medical aid in dying.

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Illness IT Medical Provider 144

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. It is appropriate for all patient populations, and it is developed specifically for the palliative care and hospice populations. Why do this?

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Families Family Patient-Centered Patients 108

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.

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Provider Medical Hospital Patient-Centered 19

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.” I give you Dr. Pamela Wible. Dr. Pamela Wible soon discovered why. To be real.

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Clinic Nurse Practitioner IT Medical 246