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

GeriPal

How should we screen for cognitive impairment? Who do you think we should be screening and how should we be screening them for these symptoms? Well, so I guess it depends on what you say screening. That screening influences kind of further treatment, actually, probably more importantly, patient outcomes.

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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. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really?

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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. We and many others have tried to come up with a short, validated screening tool.

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