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

FDA Law

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

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Episode 213: Antiracism in Medicine Series – Episode 13 – Centering Asian Americans: Racism, Violence, and Health

The Clinical Problem Solvers

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) Remember that more deeply understanding your patients can provide meaning!

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AGS Beers Criteria for Potentially Inappropriate Medication Use: A Podcast with Todd Semla and Mike Steinman

GeriPal

Mike: 2019. Eric: 2019. So the intention of the AGS Beers Criteria is to provide information primarily to clinicians, although to other audience as well, but medications that we consider to be potentially inappropriate in older adults. Eric: And when was the last update? So is the plan updated every four years? Mike: Thank you.

Medical 97
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Preemies receive sucrose for pain relief—new research shows it doesn't stop long-term impacts on development

Medical Xpress

While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.

IT 53
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Do statins reduce mortality in older people? Findings from a longitudinal study using primary care records

BMJ

9 The availability of electronic health records makes it easier to follow up on patients’ health information for an extended period. This information might be available in electronic health records, however it is extremely labour intensive to pull out the information when having a large sample size, in our case over 110 000 patients.