FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

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.

IT 59

IT Provider Clinic Medical 59

PEMBlog

MAY 11, 2023

And what about the J-Tip, a device that uses pressurized gas to send medication into the subcutaneous portion of the skin – deeper than topical anesthetics? There is inconclusive evidence that it’s better than placebo for IVs too – it may help… ( see Auerbach, 2009 ). 2009 May;16(5):388-93.

Patient-Centered 52

Patient-Centered IT Provider Patients 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). Rasheeda, welcome to GeriPal.

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Complication Patient-Centered IT Patients 97

PEMBlog

OCTOBER 18, 2023

No medication exposures. Clinical features of neonatal toxic shock syndrome-like exanthematous disease emerging in Japan. The rash had since evolved into full-body erythroderma sparing the palmar and plantar surfaces. He continued to have normal wet diapers and green-seedy stools without blood or mucus. Mom was GBS negative.

Diagnosis 59

Diagnosis Diagnose Illness Patients 59

GeriPal

NOVEMBER 7, 2024

And the main topic of today is a paper in Annals of Internal Medicine , Maria first author, that addressed the tradeoffs between initiating dialysis vs continued medical/supportive management. Susan 01:36 To reflect continuing medical management versus starting dialysis, which is what Maria’s wonderful paper goes through.

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Management Patient-Centered Patients IT 116

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 Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

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Screening Checkup Integrated Care Electronics 52

Permanente Medicine

JUNE 25, 2025

per 100,000 in 2009 to 23.5 Corley, MD, PhD, is chief research officer at The Permanente Medical Group and a research scientist at the Kaiser Permanente Northern California Division of Research. What we found is truly impressive: Screening rates among KPNC patients nearly doubled — from 37.4% in 2000 to 79.8%

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Screening Preventive Care Preventative Care Patient-Centered 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. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. Cochrane Database of Systematic Reviews Review.

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Patient-Centered IT Healthcare Medical 96

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. medical or scientific/technical representative or department). medical or scientific/technical representative or department).

Specialization 59

Specialization Medical IT Clinic 59

GeriPal

OCTOBER 20, 2022

Alex: And we are also delighted to welcome Devika Nair, who is a nephrologist at Vanderbilt University Medical Center in Tennessee Valley VA Healthcare System. That includes many medical specialists, surgical specialists, many specialists and many other disciplines who are on our older adults team. Rasheeda, welcome to GeriPal.

Complication 52

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. And then we had clinical decision support. What is a clinical decision support? Long overdue.

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Patient-Centered IT Hospital Patients 77

GeriPal

MARCH 7, 2024

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. That’s probably too medical. I’m using my medical brain. Jane: Right.

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Provider Illness IT Healthcare 117

GeriPal

MARCH 24, 2023

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. Reading Ira’s article, it essentially was the VITAS Medical Director job description. Again, if it’s going to improve quality and not come to cost of clinical care, we need to support it.

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IT Provider Patients Families 114

GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. Many years ago for the first study; I believe it was in 2009, 2010; I met with Susan Mitchell at the Institute for Aging Research, and told her that I wanted to study the use of feeding tubes for people with advanced dementia. Ruth: Sure.

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Nurse Practitioner Hospital Families Family 60

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 66