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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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Episode 275: Anti-Racism in Medicine Series – Episode 19 – Reframing the Opioid Epidemic: Anti-Racist Praxis, Racial Health Inequities, and Harm Reduction

The Clinical Problem Solvers

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. Published September 2019. Racial/Ethnic and Geographic Trends in Combined Stimulant/Opioid Overdoses, 2007–2019.

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 01:34 Yeah, right on.

Illness 107
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Stories We Tell Each Other to Heal: Ricky Leiter, Alexis Drutchas, & Emily Silverman

GeriPal

So has a special resonance for, I think, a lot of people who are Tragically H ip fans. It was late on a Friday afternoon in December 2019. It was my first concert without my parents. And actually this song was the last song they played live ever after, you know, before their lead singer, Gord Down ie , unfortunately died of a gbm.

IT 107