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

FDA Law

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64
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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic 52
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You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

Special thanks to Todd Florin, MD, MSCE who contributed to this post – he is also an expert on respiratory and infectious emergencies. Provider level factors such as newly autonomous trainees, advanced practice professionals, and clinicians with infrequent exposure to pediatric respiratory illnesses may lead to overreliance on tests.

Asthma 52
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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

So I think we’re poised now with the guide model and with the evidence we have about healthcare utilization, impact on caregivers, course of dementia, comorbidity management and all of that. And either of those could be given to the patient or an informant. So there are some studies going on in that direction as well.

Screening 119
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PC Trials at State of Science: Tom LeBlanc, Kate Courtright, & Corita Grudzen

GeriPal

We all, when bombarded with information have to take certain elements of a decision and focus on those; and in the ICU, you can imagine, we’re bombarded with information a lot. I treat patients with acute leukemias and related diseases, so I kind of know some of this from my own clinical practice. Why another study?

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Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

GeriPal

It’s really special to be here and to be talking about this paper, which was really important to Randy. He really practiced what he preached. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. Just love your thoughts.