FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system.

Management 45

Management Manufacturing Supply Chain Provider 45

GeriPal

JUNE 20, 2024

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. I suggested even flow. That’s a good one.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. The Agency will hold as many as three public workshops during PDUFA VII related to rare disease endpoint development.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. The Agency stated that the most common reason for a clinical hold of a Phase 1 study under an investigational new drug (IND) is related to safety. The workshop is also discussed in Cell & Gene here and here.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

ABIM

APRIL 24, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. The following is a summary report of the spring meeting.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? But before we do, do you have a song request? I think Kellie, do you have it? Alex: Yeah.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

OCTOBER 12, 2023

Gretchen: Yeah, I think probably the underlying story here is that I’m really good at doing negative randomized clinical trials, but there is a good thing about doing a big clinical trial, which is that you get tons of data even if you don’t end up with the result that you want. Justin, welcome to GeriPal. Justin: Hello.

IT 128

IT Families Family Patient-Centered 128

Maine Academy of Family Physicians

OCTOBER 22, 2023

I also spent one day at the Maine Family Planning clinic in Augusta, shadowing the head clinician, Lindsey Piper, NP. Between routine care, medication management, and patients who opened up about their mental health struggles, it was clear that a strong baseline of trust had been established.

Medical Student 40

Medical Student Family Medicine DO Patient-Centered 40

GeriPal

SEPTEMBER 19, 2024

Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Give too little – it may not work. But before we jump into that topic, Jennifer, do you have a song request for Alex? Jennifer 01:20 I do have a song request for Alex. Saw them play a couple times.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

APRIL 21, 2022

Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. Look also for a forthcoming article by Mike and Redwing in Journal of Pain and Symptom Management on poetry as a healing modality, to be published mid May (will add link when out). To let it go. . AlexSmithMD . Wounded Healer poetry sessions . Eric: Yeah?

Patient-Centered 93

Patient-Centered IT Community Illness 93

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. Health care professionals are human, and as humans we experience loss both in and out of work. Turns out, it’s maybe not. Eric: And why’d you pick that song?

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102