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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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

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. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

Clinic 52
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. Background. 21 U.S.C. §

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. DEA seeks to prevent, detect and eliminate the diversion of controlled pharmaceuticals while ensuring their availability for legitimate medical, scientific and industrial purposes. Background. 21 U.S.C. §

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SIUU-SIUU-Sudio: FDA Finalizes Guidance on SIUU and Distribution of Off Label Information

FDA Law Blog

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).

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Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. She happened to focus on some specific for-profit hospice providers. They were all actually publicly traded or private equity owned for-profit hospice providers. Welcome back to GeriPal, Lauren.

IT 114
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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

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. primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Why do so many (most, all??)