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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Upon receiving the AI letter, appoint a lead person and disseminate the letter among team members for review. Average Number of Industry Days to MDUFA IV Decision 54.69 Average Number of Total Days to MDUFA IV Decision 127.31

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Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law Blog

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is.

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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. When you think about getting your groceries, going to doctor’s appointments, going to religious services, if that’s important to you. I think I’m really drawn to hard conversations. Weren’t those the days?

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

GeriPal

2018 Systematic Review of Systematic Reviews on ACP. So I do think it often does happen that younger adults appoint a surrogate when they engage in estate planning, for example. And I don’t think necessarily, that appointment needs to be a medicalized process. Alex: What did it changed to after 2018? AlexSmithMD.

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GeriPal Takeover! Nancy Lundeberg and Annie Medina-Walpole

GeriPal

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Alex joined in 2018.

IT 65
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How to Make an Alzheimer’s Diagnosis in Primary Care: A Podcast with Nathaniel Chin

GeriPal

And then the family tells me they can’t keep an appointment, they can’t manage their finances. Eric 18:39 Yeah, I do worry a little bit because I recently had a primary care appointment. Of these interventions in those individuals. Well, there’s my complaint. What is that screening test gonna do for me?

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8 Reasons Why Family Physicians are the Actual Stars of Medicine

Family Medicine Initiative

million people in 2018), shows that the longer you know your GP, the better off you are. Because chronic diseases are largely managed in primary care and are therefore the GPs’ daily business: Patients with multimorbidity account for 78% of GP appointments (based on 100,000 UK patients). of healthcare costs in the EU 2018.