FDA Law Blog

NOVEMBER 1, 2023

We recount a few milestones along the road here: 1997 ASR Rule restricts sale, distribution of analyte specific reagents; FDA asserts authority over LDTs but articulates enforcement discretion policy 1998 FDA denies Citizen Petition submitted in 1992 on behalf of several clinical laboratories challenging agency authority over “home brew” tests 2006 (..)

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

GeriPal

APRIL 14, 2022

On today’s podcast we talk with three experts on buprenorphine on why, when, and how to use it in serious illness. Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Katie, before we jump into the topic of buprenorphine in serious illness, what’s the song request?

Illness 103

Illness Patient-Centered IT Patients 103

GeriPal

OCTOBER 5, 2023

Summary Transcript Summary Communicating about a serious illness is hard. Last week’s podcast we talked about the challenge around miscommunication in serious illness. Why it’s such a natural way to explain the condition of someone with an acute critical illness that’s threatening their life. Eric: Why is it?

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Illness IT Patient-Centered Families 136

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. Four percent. So less than six months to live.

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Illness IT Medical Provider 144

GeriPal

JULY 28, 2022

GeriPal post on “fast food” style palliative care in chronic critical illness. Areej: So when I was in college, I had a close friend who had a serious illness and actually died as a result of cancer. I entered medical school and I did a course that was offered that’s called living with a life threatening illness.

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

DECEMBER 8, 2022

Unpacking characteristics of spirituality through the lens of persons of colour living with serious illness: The need for nurse-based education to increase understanding of the spiritual dimension in healthcare. What Mattered Then, Now, and Always: Illness Narratives From Persons of Color. Tell me about your illness.

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

GeriPal

FEBRUARY 29, 2024

Not the most common circumstances that people with serious illness face where attention and understanding of what my goals and values are. And, that’s to help people who have serious illness, that’s to help people who have diseases of aging at a younger age, people who are homeless, people who are incarcerated.

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IT Patient-Centered Illness Education 127

GeriPal

DECEMBER 15, 2022

So during the dissertation, that was a method for my PhD research and that’s related to… I was learning about African American elders experiences of psych-social-spiritual healing and serious illness. Tell me about your illness. So like I said, I got to meet Thor, I believe it was May, 2016. Depends om my audience.

IT 106

IT Patient-Centered Healthcare Illness 106

GeriPal

JUNE 30, 2022

We think there are some cases, certain kinds of illnesses or conditions or operations, where people have the surgery and never get out of bed again. So for example, tracheostomies frequently occur in patients who are quite ill, but it’s not the trach itself that tends to lead to the mortality, it’s their generalized illness.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

MARCH 28, 2024

Alex: Recently you talked about the other trial, also with a nudge, and that was non-cancer, serious illness. Eric: And that’s similar to the 2016 JAMA paper, right? Did it negate everything from the 2016 trial?Palliative Alex: We had you on just recently, the podcast. We’ve had you on twice before.

Consulting 116

Consulting Patient-Centered Patients IT 116

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

PEMBlog

MARCH 27, 2024

2016 Jan;37(1):3-15; quiz 16-7, 47. But again, metabolic GI illness, interrupt other interruptions in feeding schedule, intense exercise. It helps more people find the show, and therefore more people learn about the care of ill and injured children in the emergency department. In: StatPearls [Internet]. Pediatr Rev. Pediatrics.

Consulting 59

Consulting Individual Families Family 59

GeriPal

AUGUST 24, 2023

Fox gives patients hope there may be a place that illness doesn’t touch Depression is a Liar Why is Being a Patient Such a Difficult Pill to Swallow Better Patient Care Calls for a ‘Platinum Rule’ to Replace the Golden One. And that includes what we call illness-related concerns, the things that are directly mediated by the illness itself.

Patient-Centered 98

Patient-Centered Patients IT Illness 98

GeriPal

AUGUST 25, 2022

And yet, disenrollment from hospice, either due to patient/family revoking the benefit or stabilization of illness (extended prognosis) is remarkably high for people with dementia among some hospices. I think there just needs to be, in the case of people with dementia, that just better care along the trajectory of illness.

Families 107

Families Family IT Patients 107

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Older adults with severe mental illness (SMI) who develop dementia are a particularly complex and understudied population with various healthcare needs. Dataset: Health administrative data from 380,124 Quebecers between 1996 and 2016. Study Design and Analysis: Retrospective cohort study.

Diagnosis 130

Diagnosis Healthcare Illness Primary Care 130

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

In 1996, a variant of H5N1 was documented overseas that resulted in a severe illness in birds and was designated as highly pathogenic avian influenza (HPAI). Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 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. So the palliative performance scale, or PPS, is essentially a tool to help clinicians with prognostication for seriously ill or palliative care populations.

Families 108

Families Family Patient-Centered Patients 108

FDA Law Blog

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. In its decision, the court first addressed PhRMA’s standing to sue.

Manufacturing 40

Manufacturing Patients Insurance Government 40