FDA Law

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

Rao Doctor

APRIL 3, 2025

Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. The choice of method depends on the patient’s age, condition, and preference, with rectal measurements often being the most precise for infants and young children.

Diagnosis 130

Diagnosis Management Illness Diagnose 130

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

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

Family Medicine 40

Family Medicine DO Family Families 40

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. Learn about using the low dose buprenorphine patch: . Eric: And why Under Pressure.

Illness 102

Illness Patient-Centered IT Patients 102

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. And you wrote, actually, a beautiful GeriPal blog about it a while ago.

Illness 136

Illness Patient-Centered Screening Clinic 136

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

SEPTEMBER 22, 2022

Have you ever had that moment when talking to a patient, when you realized that the phrase you just uttered, which you’ve uttered a hundred times before, came out rote and scripted? And in response, the family or patient looked at you like you were from another planet? Summary Transcript Summary. Yeah, I’ve been there too.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

DECEMBER 19, 2024

A NY Times article titled Should Patients Be Allowed to Die From Anorexia ? That’s how do we treat the mental health needs of patients with serious medical illness? So in those cases, can we adopt an approach to mental health care that centers primarily around quality of life of patients and their families?

Illness 101

Illness Mental Health IT Patient-Centered 101

FDA Law

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

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.

Illness 144

Illness IT Medical Provider 144

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” So this, I think we had three or four consults.

Patient-Centered 128

Patient-Centered IT Patients Consulting 128

GeriPal

APRIL 26, 2024

Who spends the most time with the patient in the infusion center? And we’re delighted to welcome Jenny back to the GeriPal podcast, Jenny Blumenthal-Barby, who’s a philosopher and bioethicist and associate director for the Center for Medical Ethics and Health policy at the Baylor College of Medicine. Doing home care?

Patient-Centered 119

Patient-Centered IT Patients Consulting 119

GeriPal

FEBRUARY 2, 2023

Alex: This was the National Palliative Care Research Center’s Annual Foley retreat for investigators, researchers. Bob: Well, it changed how I helped talk to people who are seriously ill and it acknowledged some of the feelings that I have and helped me be more aware of those feelings when I’m taking care of patients.

IT 104

IT Medical Student Medical Families 104

GeriPal

DECEMBER 12, 2024

Surrogates often either dont know what patients would want, or think they know but are wrong, or make choices that align with their own preferences rather than the patients. The first one is that a lot of patients, particularly the end of life, probably the majority of them, can’t make their own decisions. Good to be here.

Patient-Centered 108

Patient-Centered IT Patients Healthcare 108

FDA Law

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. These firings will stretch the Centers resources to take on its existing workload, let alone handle thousands of complex and innovative LDTs.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

PEMBlog

MAY 9, 2024

Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. All five of those patients with meningitis had a concerning exam, and four out of five were less than 12 months of age.

Illness 59

Illness Vaccination Families Family 59