FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Patients Patient-Centered Clinic Medical 59

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

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

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. And we can talk about that later in terms of potential clinical implications that may have code. How do you think about this from a clinical perspective when you’re seeing individuals in your office?

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IT Patient-Centered Patients Clinic 121

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.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

GeriPal

JANUARY 12, 2023

So that’s one, this patient-centered geriatric assessment and management approach. Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics. And so how can we adopt these five elements for the unique environment that we’re in?

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Hospital Patient-Centered IT Nurse Practitioner 101

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

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. And that’s how we connected.

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IT Families Family Patient-Centered 129

GeriPal

SEPTEMBER 19, 2024

Eric 07:31 A clinical perspective, why is it important to test this stepped care model versus implementing more? And now when I think about the clinic at Duke, when we’re really running on all cylinders, we can get ourselves up to a five, six, seven week wait for a new palliative care referral. Jennifer 07:31 From.

Patient-Centered 120

Patient-Centered IT Patients Hospital 120

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). Alex: It sounds like that might be a part of the workshops that you run.

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. And so we just designed a couple of workshops to train some facilitators. Turns out, it’s maybe not. It has to. ” And what a brave thing to do.

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Healthcare Professional Healthcare IT Relationship 103