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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 By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.

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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. Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is. Eric: What’s the song?

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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. 2018 Systematic Review of Systematic Reviews on ACP. All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics.

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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.

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Keynote: Finding your bliss—beating physician “burnout”

Pamela Wible MD

Physician burnout describes a dangerous mix of emotional exhaustion, depersonalization, and a loss of meaning in work. It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. But is it really burnout—or something more serious? To be real.

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