FDA Law Blog

JUNE 21, 2021

Sasinowski — On June 17, 2021, FDA gave notice of an upcoming public workshop focused on clinical trial designs for progressive multifocal leukoencephalopathy (PML). The virtual workshop will take place on September 21, 2021, and a public docket seeking comments on the workshop will remain open until November 1, 2021.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The first scenario is a healthcare facility using a medical device 3D-printing production system. This guidance document is still in effect today.

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LEAD Physician

SEPTEMBER 26, 2022

Foster Collaboration Patients are the most critical part of the healthcare equation. Aspiring medical leaders should look for opportunities to enhance their leadership skills through CME courses, seminars, workshops, and conferences. Physicians can take feedback from others and use it to improve their leadership skills continuously.

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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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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The first scenario is a healthcare facility using a medical device 3D-printing production system. This guidance document is still in effect today.

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ABIM

APRIL 24, 2025

She emphasized the unique challenges of private practice, including business models, recruitment difficulties, healthcare system pressures and a disconnect from the certification process, though she acknowledged the growing support for the LKA over the traditional exam. The following is a summary report of the spring meeting.

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GeriPal

DECEMBER 2, 2022

Summary Transcript Summary. What would it take to transform dementia care? Alex: We have a full house today. We’re delighted to welcome Judy Long, who’s a palliative care chaplain at UCSF and a caregiver. Judy, welcome to the GeriPal podcast. Judy: Thank you. It’s great to be here. Alex: Great. So take it away. When was that, 2010?

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FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary sup??

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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

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites.

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FDA Law Blog

JULY 7, 2022

A flurry of activity followed the 2012 meeting including several workshops organized by the Brookings Institute and the launch of a new (and apparently now abandoned) acronym by FDA: NSURE – Nonprescription Drug Safe Use Regulatory Expansion. Among other things, the applicant would need to include a statement of the necessity of the ACNU.

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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.

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FDA Law Blog

FEBRUARY 28, 2022

This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”. The FDA webinar information can be found here.

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My Green Doctor

MAY 29, 2025

This increased disease burden hits hardest in areas with limited healthcare infrastructure, compounding the human and economic toll. And through our roles — as healthcare professionals, citizens, and ambassadors — we can drive the kind of informed, compassionate leadership the world so urgently needs.

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FDA Law Blog

MAY 3, 2022

By Dara Katcher Levy — A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion.

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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.

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GeriPal

OCTOBER 3, 2024

As BJ MIller writes in the foreword, “ May this book be a portal — a way for us to move beyond the unwise territory of trying to ‘do it right’ and into the transcendent terrain of noticing what we can notice, loving who we love, and letting death — like life –surprise us with its ineffable beauty. I got questions. Thank you, Alex.

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GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. How do you find time to write and also be doctors and academic professors? In all seriousness, you don’t actually have to want to write a book to be interested in this podcast.

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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.

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GeriPal

JUNE 26, 2025

-Alex Smith Additional links mentioned by Tsai-Chin Cho: – Wealth shocks and mortality in the US – Change in marital status as a risk for wealth shock ** NOTE: To claim CME credit for this episode, click here ** Transcript Eric 00:11 W elcome to the GeriPal p odcast. This is Eric Widera. Alex 00:12 This is Alex Smith. Is it you, Rebecca?

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GeriPal

NOVEMBER 3, 2022

That was the lesson I learned from reading a new book edited by Matt Loscalzo along with Marshall Forstein called “ Loss and Grief: Personal Stories of Doctors and Other Healthcare Professionals ”. 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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GeriPal

APRIL 21, 2022

Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. The impossiblity which is life, which is everything, and death, which is the end of life. As Mary Oliver tells us In Blackwater Woods , and I’m paraphrasing here, we must to hold it to our bones, knowing our lives depend on it, and when the time comes, to let it go.

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GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Jessica, welcome back to GeriPal. So here is a little bit.

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