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). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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Clinic IT Utilities Government 64

GeriPal

OCTOBER 13, 2022

We have a discussion about the decision to remove race, a social construct, from clinical risk calculators (though I’m not 100% sold that race should always be removed – if removal is likely to worsen disparities for example – at least until a superior race-blind calculator can be developed). Eric: Welcome to the GeriPal podcast.

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Complication Patient-Centered IT Patients 97

CDOCS

APRIL 14, 2021

& When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & But, more importantly to me clinically, was the improvement in radiopacity.&

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PEMBlog

MAY 11, 2023

There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). It has also been shown to increase the likelihood of success.

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FDA Law Blog

OCTOBER 4, 2021

Circuit told FDA, for the second time , that the plain text of the Orphan Drug Act unambiguously required FDA to award orphan drug exclusivity to any orphan designated drug, even if that designation was based only on a “plausible hypothesis” of clinical superiority that ultimately could not be confirmed. Earlier this year, the D.C.

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GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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GeriPal

NOVEMBER 7, 2024

About half of patients who are over the age of 65 start dialysis with a GFR of over 9, which is sort of the level below which we have clinical trial evidence for suggesting that there may not be a benefit to starting at that level of GFR. Do target trials differ from randomized trials and “ordinary” observational studies, or do they differ?!?

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GeriPal

MARCH 2, 2023

This long and sordid history of gabapentin and pregabalin is beautifully described in Seth Landefeld and Mike Steinman 2009 NEJM editorial. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Cochrane Database of Systematic Reviews Review. Annals of IM.

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Permanente Medicine

JUNE 25, 2025

per 100,000 in 2009 to 23.5 By building an integrated, patient-centered colorectal cancer screening program, we doubled screening rates, cut deaths by 50%, and made major strides in closing racial disparities in outcomes. A third of U.S. in 2000 to 79.8%

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Screening Preventive Care Preventative Care Patient-Centered 52

Permanente Medicine

APRIL 29, 2025

Early screening helps erase racial health disparities The study showed a significant reduction of colorectal cancer deaths among Black patients, which decreased from 52 per 100,000 in 2009 to 23.5 Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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GeriPal

OCTOBER 20, 2022

And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. There’s the complications associated with immune senescence, comorbidities, atypical clinical presentations. How to make your voice heard and get involved.

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Complication Patient-Centered IT Patients 52

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC.

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Patient-Centered IT Hospital Patients 77

FDA Law Blog

JANUARY 22, 2025

And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft Good Reprint Practices guidance since 2009. In any event, you whippersnappers should look up the album No Jacket Required its a classic.) This final guidance (16 years in the making!)

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Specialization Medical IT Clinic 59

GeriPal

MARCH 7, 2024

But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer. When I heard Bubbles Up, I was really struck by two things. How do you see the light? You were a what?

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GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. This study explored nursing home organizational factors and staff perceptions that are associated with the variation in care for residents with advanced dementia. Welcome to the GeriPal Podcast, Caroline. Caroline: Thanks, Alex. Thanks, Alex.

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PEMBlog

APRIL 4, 2025

Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. So what are we gonna go over in this episode?

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Vaccination Illness IT Clinic 68