FDA Law Blog

SEPTEMBER 10, 2023

Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § An interesting addition in the final guidance is that it explains that the topics discussed “apply to any type of RWD, including data on products used in clinical practice under an emergency use authorization (EUA).”

Provider 108

Provider Patient-Centered Clinic Clinical Practice 108

Louisville Lectures

APRIL 9, 2021

He then describes the lifecycle of Sars-CoV-2 and the events surrounding the Cytokine Storm. After, he explains the clinical presentation and current commendations for pharmacologic management and finally, the vaccines in phase 3 trials. Mark Burns gives an update on COVID-19 by first discussing its history and epidemiology.

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Board-Certified Internal Medicine Vaccination Management 52

FDA Law Blog

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

AUGUST 1, 2024

So if you already have a condition, you might be able to prevent events. So I’m hearing, and I’d love to talk about specific diets and maybe the evidence for them, but before we do that, how should we ask about this in our clinics? Eric 18:14 Elizabeth, how do you bring it up in your clinic? Yeah, absolutely.

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IT Diabetes Chronic Disease Patient-Centered 116

GeriPal

DECEMBER 1, 2023

Summary Transcript Summary There is a growing push to change how we define Alzheimer’s disease from what was historically a clinically defined syndrome to a newer biological definition based on the presence of positive amyloid biomarkers. So too systolic hypertension in elderly people, clinical trials. Alex: That’s right.

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IT Clinic Illness Hypertension 115

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. Folks who were first homeless after 50, there was an event, and usually those events could be described in one of four categories.

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Mental Health IT Community Individual 123

Physician's Weekly

JUNE 26, 2025

Within an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs. His clinical study was ending. But for Dressen and others convinced the vaccines injured them, their experiences were symptomatic of a well-intentioned but flawed U.S.

Vaccination 52

Vaccination Patient-Centered Government IT 52