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

FDA Law

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69

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10 Things To Do To Keep Your Heart Happy

Georgetown Pediatrics & Family Medicine

In addition to a special day called Valentines, I would like to bring awareness to why we should keep our hearts healthy. According to the CDC, “About 697,000 people in the United States died from heart disease in 2020– that’s 1 in every 5 deaths”. Your heart is undoubtedly one of the most important organs in your body.

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RCT of Palliative Care for Heart Failure and Lung Disease: David Bekelman and Lyndsay DeGroot

GeriPal

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. If I remember correctly, I think the average was, people were screening positive for depression in this study. David: Exactly.