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.

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Management Manufacturing Supply Chain Provider 45

FDA Law Blog

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

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit.

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Board-Certified Board-Certified Physicians Community Government 40

FDA Law Blog

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 With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.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

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 120

FDA Law Blog

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.

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Manufacturing Engineering Clinic Provider 59

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

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Hospital Patient-Centered IT Nurse Practitioner 100

FDA Law Blog

FEBRUARY 11, 2025

Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees. Click here to learn more about the Opioid & Abuse Management Congress. By Larry K.

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Management Hospital Healthcare Patients 59

Maine Academy of Family Physicians

OCTOBER 22, 2023

I observed multiple fascinating procedures and patient interactions throughout the externship, and I am grateful to have had the opportunity to glimpse the day-to-day of this field. At the Family Medicine office, I observed the close relationships fostered between Dr. Der Simonian and her patients.

Medical Student 40

Medical Student Family Medicine DO Patient-Centered 40

GeriPal

OCTOBER 12, 2023

Summary Transcript Summary For surgeons and patients, deciding if and when to operate can be challenging. Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. We hope you enjoy this episode. I did it before and this guy, he was 85, but he was climbing Mount Everest.”

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IT Families Family Patient-Centered 128

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. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

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Patient-Centered IT Patients Hospital 119

GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. 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.

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.

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Healthcare Professional Healthcare IT Relationship 102