FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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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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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.

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Patient-Centered Manufacturing Clinic Provider 52

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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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.

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Manufacturing Engineering Clinic Provider 59

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dave noted the Diplomate Professional Profile’s potential outside of Specialty Board discussions with data that could be valuable to patients with specific needs and conditions.

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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

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. 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.

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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. And that’s how we connected.

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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. Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. Isn’t that what we always work with, with patients, with our colleagues, with ourselves? AlexSmithMD . Advance Care Planning.

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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. It just absolutely has to.

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