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

FDA Law Blog

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Brad’s not a pediatric medical geneticist.

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Private Equity Gobbling Up Hospices plus Hospice and Dementia: Melissa Aldridge, Krista Harrison, & Lauren Hunt

GeriPal

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

Families 106
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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Do they have documents in the record like medical orders for life sustaining treatment or a healthcare proxy? Eric 19:30 Should we add that to special effects as our producer?

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RCT of Chaplaincy: Lexy Torke, Karen Steinhauser, LaVera Crawley

GeriPal

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” I don’t see a lot of those out there.

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