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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The presentation should be accompanied by the reprint and the reprint, itself, must meet the criteria articulated in the SIUU Guidance for reprints.

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Our esteemed publications should ensure that investigations that utilize racial variables follow these guidelines before being published. Examining the Potential Impact of Race Multiplier Utilization in Estimated Glomerular Filtration Rate Calculation on African-American Care Outcomes. 2009 May;139(1):47-57. 2019;322(2):113-114.

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. For more on FDORA’s other provisions, see HPM’s complete summary here ). However, there are signs that FDA is receptive from a policy perspective to alternative methods.

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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. 2009 Nov;27(4):655-67, ix. 2009 Jun;21(3):196-202. Patient that are agitated should always be treated with dignity and respect. Coburn VA, Mycyk MB. Physical and chemical restraints. 2009.07.003.

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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

It was really at the level of the ED across 33 EDs in random order, and then tried to see if we could make a difference in healthcare utilization, primarily the primary outcome was admission to the hospital, acute care admission. Would it have changed potentially utilization rates like hospice utilization?

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End-of-Life Doulas: A Podcast with Jane Euler, Beth Klint, and John Loughnane

GeriPal

In fact, I worked for senior care options payer-provider in Massachusetts, where I am coupled end-of-life care from hospice back in 2009. it looks a little bit like VBID back in 2009, because I realized that populations are traditionally underserved and have mistrust of the healthcare system. What was the value proposition?

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