FDA Law Blog

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. FDA replied that its definition of strength including concentration was clear even in 2009. FDA thus disagrees that such differences are not clinically meaningful.

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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

PEMBlog

MAY 11, 2023

There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). Pediatr Emerg Care This randomized, double-blinded, placebo-controlled trial in infants 0-3 months old getting an LP, younger than 3 months, presenting to the ED meeting clinical criteria for LP.

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Patient-Centered IT Provider Patients 52

CDOCS

APRIL 14, 2021

& When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& </span></p> <p><span style="font-size:14px;">The 4-Y composition of the 3M Chairside Zirconia has provided excellent clinical results with a unique blend of esthetics and strength.&

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IT Patients Provider Appointment 52

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). So you’re right.

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Complication Patient-Centered IT Patients 97

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. 6 to less than 17 years of age).

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IT Patients Provider Manufacturing 52

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. 2009, yeah, 2009. Clinical experience. One of my favorite articles.

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Management Patient-Centered Patients IT 116

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. This final guidance (16 years in the making!) medical or scientific/technical representative or department).

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Specialization Medical IT Clinic 59

GeriPal

OCTOBER 20, 2022

This office is tasked with providing aging policy research and recommendations within ASPE, including long term care and the National Alzheimer’s Project Act. 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.

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Complication Patient-Centered IT Patients 52

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. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? I understand that it can be a hard place clinically.

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Patient-Centered IT Healthcare Medical 96

GeriPal

MARCH 24, 2023

Full disclosure, I talked with Ava Kofman a bunch while she was preparing that article, and I thought based on my professional experience working in hospice, things that I had seen, that she raised a lot of issues that I had personally encountered in my clinical experience. She happened to focus on some specific for-profit hospice providers.

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IT Provider Patients Family 114

GeriPal

APRIL 10, 2025

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. Alex 00:31 And we’re delighted to welcome Fernanda Bellolio, who is an emergency medicine physician and professor of emergency medicine at the Mayo Clinic. Corita 00:30 Thank you.

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Patient-Centered IT Hospital Patients 77

GeriPal

MARCH 7, 2024

We are delighted to welcome Jane Euler, who is lead doula and co-founder of Present for You, which is a benefit LLC company that provides doula support at the end-of-life. We are doulas for those with serious illness and those at end-of-life, just a longitudinal relationship, nonmedical support to provide presence. Jane: Right.

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Provider Illness IT Healthcare 117

GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. The Lived Experience of Providing Feeding Assistance to a Family Member with Dementia. Well, I’m a geriatric nurse practitioner and I provided care to over 800 nursing home residents in 11 different nursing homes. Ruth: Sure.

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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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