FDA Law

JULY 17, 2024

As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law

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.

Patients 59

Patients Patient-Centered Clinic Medical 59

FDA Law

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

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

GeriPal

JUNE 20, 2024

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. Someone else suggested, “Under Pressure,” but we’ve done it already. We settled on, “Oops…I did it again,” by Britney Spears. I suggested even flow. That’s a good one.

IT 120

IT Patient-Centered Patients Clinic 120

ABIM

APRIL 24, 2025

Mansoor underscored disparities between academic and community settings, noting that community rheumatologists referring patients to academic centers are often viewed as practicing “inferior” medicine despite managing complex cases with suboptimal local resources. The following is a summary report of the spring meeting.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

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

FDA Law

MAY 4, 2023

FDA has also launched a series of five public workshops on issues related to DHTs in regulatory decision-making. For example, the draft guidance notes that the trial’s data management plan should include information about the multiple sources of data collection. Finally, the draft guidance addresses the use of software in a DCT.

Clinic 59

Clinic Telehealth Provider Electronics 59

GeriPal

OCTOBER 12, 2023

Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. And, surgeons often spend the majority of their conversations with patients describing anatomical details and exactly how they plan to ‘fix it’ , with little discussion of what that ‘fix’ will do for a patient’s overall goals.

IT 128

IT Families Family Patient-Centered 128

Maine Academy of Family Physicians

OCTOBER 22, 2023

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. As the Maine delegate, I attended Congress business sessions, participated in resolution writing workshops, and voted for candidates in elections.

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