FDA Law

JANUARY 12, 2025

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.

Clinic 64

Clinic Relationship Provider IT 64

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Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in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

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 114

Patient-Centered Illness Healthcare IT 114

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 Nurse Practitioner 102

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.

DO 40

DO Family Medicine Family Families 40

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. Katie, welcome back to GeriPal. What is it called?

Illness 135

Illness Patient-Centered Screening IT 135

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 104

IT Patient-Centered Healthcare Illness 104

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 ? They are recruiting for a Medical Director of Palliative Care Services to lead and grow innovative outpatient and inpatient palliative care programs. That’s how do we treat the mental health needs of patients with serious medical illness?

Illness 100

Illness Mental Health IT Patient-Centered 100

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). 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. What’s up with Medical aid in dying in Canada?

Illness 144

Illness IT Medical Provider 144

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

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 117

Patient-Centered IT Patients Hospital 117

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 127

Patient-Centered IT Patients Consulting 127

GeriPal

APRIL 26, 2024

Who spends the most time with the patient in the infusion center? Alex: We are delighted to welcome Bryanna Moore, who is a philosopher and bioethicist, and she’s at the University of Texas Medical Branch where she also directs the clinical Ethics Fellowship. So this, I think we had three or four consults.

Patient-Centered 118

Patient-Centered IT Patients Consulting 118

GeriPal

FEBRUARY 2, 2023

Alex: This was the National Palliative Care Research Center’s Annual Foley retreat for investigators, researchers. And you’re supposed to read the medical literature and basically I have sort of found that the medical literature are not the books that have helped me get better or smarter. Eric: Yeah.

IT 103

IT Medical Student Medical Family 103

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 107

Patient-Centered IT Patients Healthcare 107

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. Obviously, you should ask about immunization status and whether or not the child has any underlying medical or neurologic problems or developmental delay. Labs just aren’t necessary.

Illness 59

Illness Vaccination Families Family 59