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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law

Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. See 42 U.S.C. 1320a-7b(b). Today, these two documents are key in navigating speaker programs in the industry.

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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. That can be incredibly informative. We’re doing this also through the inpatient portal because we were trying to get as much information in there as possible.

IT 120
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Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. It’s because they literally couldn’t access the information. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers. It changes the words. Eric: Great.

IT 102
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FDA-Approved Labeling: Is Enough Enough?

FDA Law

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science.

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Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

So it’s an example of something that can start outside of the healthcare system and move its way in. Ideally, there’ll be a place in the chart that actually captures the name of that person and their contact information. First of all, this does feel primarily like a manufactured controversy. I need structure.”

Illness 72
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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? Eric 24:59 Have to release any embargoed information with us. So I can say anything I want. I am not sticking my foot in my mouth. James 06:13 So I think in most cases.

Illness 107
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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law

For each factor, the NPRM noted that DEA’s position is that additional information during the rulemaking will further inform about the appropriate schedule for marijuana. The NPRM noted that DEA “has not yet made a determination as to its views of the appropriate schedule for marijuana.”