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 discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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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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LEAD Physician

SEPTEMBER 26, 2022

Physicians must be leaders in their field to provide excellent patient care, manage a large team and coordinate between departments, and support their patient's overall health with information about prevention and maintenance. Foster Collaboration Patients are the most critical part of the healthcare equation.

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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 discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

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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.

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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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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.” FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website.

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FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

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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. Drugs currently on the market OTC would not be approved with ACNU.

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GeriPal

DECEMBER 2, 2022

This whole conference that Ab puts on, and all of the tools and resources that he provides people and families with dementia are about, how do you build on the remaining strengths? Anne, you’ve been going to a lot of conferences on arts and healthcare, and I was thinking back to Ab years ago. Eric: This is wonderful. We have to.

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Community IT Individual Patient-Centered 101

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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GeriPal

JANUARY 12, 2023

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. And then we had half day workshops to get the frontline team just really excited about being the first ACE unit in the State of Alabama.

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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.

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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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IT Medical Patients Utilities 52

GeriPal

OCTOBER 12, 2023

The problem is, that’s actually not a very good narrative for nearly everything we take care of in healthcare. Wasn’t that the Provide Your Opinion, Don’t Hide It? Alex: Alexis workshopped a couple questions with us yesterday, and we helped her make them even more challenging for you. Because I read that.

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GeriPal

OCTOBER 3, 2024

I wonder if you could say a little bit more about the meta Institute in particular and what it is that clinicians today can do to learn, to be more present and learn about the need to be thoughtful and compassionate in the care that they provide people with serious illness. Frank 08:43 Well, briefly. But it also made me think.

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IT Patient-Centered Patients Relationship 122

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. He wrote a New York Times bestseller and now we have quality and safety in every aspect of healthcare. Rosanne: I certainly do. It’s the Activity Room.

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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.

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Healthcare Professional Healthcare IT Relationship 102

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.

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GeriPal

JUNE 26, 2025

And so spouses are typically the ones for patients who provide most of the caregiving support. And that’s in addition to the financial, emotional companionship, and psychosocial support that spouses typically provide. Like if you had a magic wand, you had healthcare providers, like, one thing they. Eric 41:25 Great.

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Illness Hospital IT Patient-Centered 73

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.

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Patient-Centered IT Community Illness 93

GeriPal

AUGUST 15, 2024

This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism. We do talk about healthcare policy. Alex 33:17 Yeah, we had to workshop this. Jessica 34:30 I love it.

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