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It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law

In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially. And in this case the presentation would be compliant whether each component was shown individually, or, when combining all three sequentially.

IT 40
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Palliative Rehab?!?: Ann Henshaw, Tamra Keeney, and Sarguni Singh

GeriPal

I moved to Boston in 2015 to start my PhD and I’ve always worked clinically at MGH during the process, but I was very interested in this notion of measuring function and frailty. We provide critical education. We provide critical conversations with colleagues and families to coordinate transition planning.”

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

GeriPal

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. Basically, there’s a lot of variation amongst hospice providers.

Families 106
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FDA-Approved Labeling: Is Enough Enough?

FDA Law

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.

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Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” 2015, 2016.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.

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Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist.