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FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act

FDA Law Blog

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s But even before the House Energy and Commerce Committee acts, the Senate Health, Education, Labor and Pensions Committee held a April 26, 2022 hearing on UFA reauthorization. and more likely 15-20. and Peter Marks, M.D.,

IT 40
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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 232: Anti-Racism in Medicine Series – Episode 15 – Housing is Health: Racism and Homelessness – Clinician + Community Perspectives

The Clinical Problem Solvers

Push back against individual narratives that blame individuals for systemic injustice. Dr. Kushel detailed how the use of dehumanizing language equates to complicity in a narrative that systemically harms our neighbors with lived expertise in homelessness. Published April 5, 2019. January 18, 2019. Rothstein, R.

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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

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

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Psychedelics – reasons for caution: Stacy Fischer, Brian Anderson, Theora Cimino

GeriPal

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Alex: It’s complicated. We, for very complicated reasons, ended up with niacin. And yet there are reasons for caution. So, creating a- Alex: Control condition. Eric: Yeah.