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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 These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. 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

Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today. Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group.

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Texas invests $50M in psychedelic drug research to treat addiction

Medical Xpress

But experts say the risks can be lowered through heart screenings, close monitoring and giving magnesium before and during treatment, The Times added in its report. However, we do not guarantee individual replies due to the high volume of messages. Ibogaine can be dangerous for people with heart problems.

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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.

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The Nature of Suffering: BJ Miller and Naomi Saks

GeriPal

So there’s this, what is suffering to the individual, and is there some threshold that we could say, “This is real suffering,” or “This is the suffering we talk about in geriatrics or palliative care”? ” That’s not a spiritual screen. Pain Manag Nurs. 2023 Dec 20:S1524-9042(23)00202-3.

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Plenary Abstracts at AAHPM/HPNA: Yael Schenker, Na Ouyang, Marie Bakitas

GeriPal

And so we worked closely with a community advisory group who, through focus groups, told us how it was that black and white individuals with serious illness had wanted to be treated. The black individuals wanted to have a separate one from the white individuals. So absolutely, it is complicated. Our consultation.

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What We Now Know About COVID Prevention and Treatment: A Podcast with Monica Gandhi

GeriPal

So take a listen and if you want a deeper dive into some of the references we discuss on the podcast, here is a list: Medscape article on how “ COVID-19 Vaccines Work Better and for Longer Than Expected Across Populations, Including Immunocompromised Individuals”. it was April, 2020. I’m anxious. Talk me out of it. Monica: Yeah.