FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. Valentine — Yesterday’s FDA approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab-avwa), is historic and is of a magnitude that it may be harbinger for future Agency actions, especially in neuropsychiatric conditions. What do we mean?

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Clinic IT Private Practice Utilities 98

GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. It was refreshing to hear Scott and Kate express similar sentiments. Much more to come. And I get to play Phish, who Scott has seen about 100 times in concert. I saw them only twice.

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GeriPal

APRIL 10, 2025

I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. They got training in Vital Talk and ELNEC. They got feedback. So did it matter? Fernanda 01:16 I do have a song request.

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Patient-Centered IT Hospital Patients 77

GeriPal

AUGUST 25, 2022

Eric: Whenever I hear about for-profit, non-for-profit, the differences between them, mostly everybody turns to, I think, your 2014 paper looking at the differences between for-profit and non-for-profit. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Is it you, Melissa?

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PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. You can contact her via email at egroopman@childrensnational.org. Pediatr Rev.

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