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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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Preemies receive sucrose for pain relief—new research shows it doesn't stop long-term impacts on development

Medical Xpress

Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear. It has become the worldwide standard of care for acute neonatal pain, but it doesnt seem to be helping in the long term. Read the original article. Your feedback is important to us.

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Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

Then take a moment to reflect on your unique plate. How closely does your current diet and lifestyle reflect the above plate? Whole​ ​wheat​ ​bread,​ ​brown​ ​rice,​ ​and​ ​whole-wheat​ ​pasta​ ​are also​ ​good​ ​sources​ ​of​ ​carbohydrates. However,​ ​their​ ​whole​ ​grains​ ​are​ ​processed​ ​, and​ ​therefore,​ ​some nutrients​ ​are​ ​lost.​