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.

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Management Manufacturing Supply Chain Provider 45

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.

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Patients Patient-Centered Clinic Medical 59

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

FDA Law

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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Clinic Telehealth Provider Electronics 59

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Patients Clinic 121

GeriPal

JANUARY 12, 2023

So that’s one, this patient-centered geriatric assessment and management approach. Yes, you need some protected time for leaders to provide training and structure and oversight and ongoing quality assurance, but the heaviest sort of cost lift sometimes is redesigning the physical space.

Hospital 101

Hospital Patient-Centered IT Nurse Practitioner 101

FDA Law

FEBRUARY 11, 2025

Controlled substances are a necessary component in providing medical care to patients, and recent employee diversion incidents illustrate the continued vulnerability of hospitals. Click here to learn more about the Opioid & Abuse Management Congress.

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Management Hospital Healthcare Patients 59

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 I am interested in becoming an abortion provider and continuing to be involved with Maine Family Planning throughout my career, this experience was very meaningful.

Medical Student 40

Medical Student DO Family Medicine Patient-Centered 40

GeriPal

OCTOBER 12, 2023

I just was going to jump in and say that I think, in surgical training, the focus is, obviously, on the technical aspects and how do you do the surgery and how do you manage somebody both pre- and post-operatively. Wasn’t that the Provide Your Opinion, Don’t Hide It? We hope you enjoy this episode. Alexis: Yeah.

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IT Families Family Patient-Centered 129

GeriPal

SEPTEMBER 19, 2024

So at our cancer center, we have physicians, advanced practice providers. Jennifer 20:48 We don’t, you know, our palliative care team here in the outpatient setting is only physicians and advanced practice providers. So, for example, the intervention visits had to be delivered by a physician or advanced practice provider.

Patient-Centered 120

Patient-Centered IT Patients Hospital 120

GeriPal

APRIL 21, 2022

To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. Alex: It sounds like that might be a part of the workshops that you run. AlexSmithMD . Advance Care Planning.

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. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Turns out, it’s maybe not. Eric: Yeah.

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Healthcare Professional Healthcare IT Relationship 103