FDA Law

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).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

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. In that decision, a medical laboratory paid Marchetti percentage-based compensation for successful referrals of Medicare patients to the laboratory.

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Referral Relationship Government Healthcare 59

FDA Law

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). 25, 2014).

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Patients Patient-Centered Clinic Community 52

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Brad’s not a pediatric medical geneticist. So my special guest host on this episode is a trainee in pediatrics and medical genetics. Pediatr Rev. doi: 10.1542/pir.2014-0122.

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Consulting Individual Families Family 59

GeriPal

JUNE 29, 2023

On last week’s podcast we interviewed the medical director and the chaplain of the prison’s hospice unit (Hospice in Prison Part 1 ). This week we turn our attention to the inmates. This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time.

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IT Families Family Board-Certified 97

GeriPal

AUGUST 25, 2022

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.

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Families Family IT Patients 106

GeriPal

APRIL 10, 2025

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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Patient-Centered IT Hospital Patients 77