FDA Law Blog

NOVEMBER 1, 2023

The PR takes on two specific statutory grounds raised by the June 22, 2020 HHS memo —the requirements for “interstate commercial” and “commercial distribution”—and argues that they are not impediments to FDA jurisdiction over LDTs. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 22, 2022

In the second case, occurring from January to May 2020, a registered nurse, admitted to daily tampering of fentanyl vials and hydromorphone injectables wherein she removed the drugs from the vials replacing them with saline solution. See Press Release, DOJ, Danville Pharmacy Technician Sentenced for Federal Drug Charge (Aug. 4, 2022).

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. The PTE application for U.S.

Clinic 59

Clinic IT Provider Patient-Centered 59

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. And we invited Tamryn Gray from the Dana Farber joins us to ask insightful questions, including: What blood sugar range should we target for patients in the nursing home or hospice?

Diabetes 74

Diabetes Management Patient-Centered Family 74

GeriPal

JANUARY 30, 2025

In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. But watch out! Travel time can leave this champ vulnerable to fatigue and no-shows.

Telehealth 106

Telehealth Patient-Centered IT Patients 106

The Clinical Problem Solvers

FEBRUARY 14, 2022

Take time to learn from your patients. Our patients are not just a list of problems. She encourages us to see beyond these problems, and ask patients about their lives, challenges, and successes. Warford centered the conversation and reminded the audience that it is not just healthcare systems that are being pushed to the brink.

Community 52

Community Individual Mental Health IT 52

The Clinical Problem Solvers

MARCH 4, 2024

During this episode, we hear from Zahra Khan, an educator and editor who has written extensively on abolition in medicine, and Dr. Sayantani DasGupta, a physician-educator, prolific children’s book author and faculty at the Center for the Study of Ethnicity and Race and the Institute for Comparative Literature and Society at Columbia University.

Community 52

Community Education Patient-Centered Relationship 52

GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life.

Patient-Centered 123

Patient-Centered IT Illness Patients 123

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 116

Patient-Centered Illness Healthcare IT 116

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 133

Patient-Centered Hospital Patients IT 133

GeriPal

FEBRUARY 8, 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.

IT 137

IT Family Families Physicals 137

GeriPal

MARCH 2, 2023

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. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

JULY 11, 2021

DEA had issued a notice of proposed rulemaking in February 2020 (see our post here ). We note that the Centers for Disease Control and Prevention reported in December that over 81,000 drug overdose deaths occurred in the year ending May 2020, the highest number ever recorded during a twelve-month period.

Transportation 52

Transportation Patient-Centered Medical Patients 52

GeriPal

FEBRUARY 20, 2025

Kate and Ashwin talked about their research on the prevalence of lifetime trauma and its association with physical and psychosocial health among adults at the end of life. I’m just thinking we all went through a major traumatic event in 2020 and the subsequent years. Well, being a pretty comprehensive definition. Eric 04:19 Yeah.

IT 67

IT Patient-Centered Individual Patients 67

GeriPal

SEPTEMBER 12, 2024

Eric 04:44 Could just make you a little bit more resilient, you can increase your Rvus so you can see more patients. It’s really not about helping the patient or physician. link] ** NOTE: To claim CME credit for this episode, click here ** Transcript Eric 00:09 Welcome to the GeriPal podcast. If you were just.

IT 112

IT Healthcare Healthcare Professional Patient-Centered 112

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. Big heat waves in England in 2020, 2,224 excess deaths in the obits over the age of 65. Ruth, welcome to GeriPal.

Healthcare 130

Healthcare IT Education Community 130

GeriPal

NOVEMBER 3, 2022

You’d imagine though that our professional expertise and experiences in helping patients and families cope with loss and grief would be helpful in managing our own personal losses. And then to see her show up in our hospice unit in April of 2020, it just completely broke my heart. Turns out, it’s maybe not.

Healthcare Professional 103

Healthcare Professional Healthcare IT Relationship 103

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.”

Patient-Centered 126

Patient-Centered IT Family Families 126

GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. 2020 Hospital at Home-Plus: A Platform of Facility-Based Care. But we ended up doing, basically, a case series of… I think it was 18 or 20 patients or so.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

The Clinical Problem Solvers

DECEMBER 2, 2020

Reflection Question: How can I best communicate the importance of social interventions to my extended family, community, and patients?) The emotional and physical fatigue associated with such immense loss of human life is leading to burnout among the very group that is required to address this disease. 2020, September 20).

Community 52

Community Internal Medicine Chronic Disease IT 52