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FDA Creates a New Advisory Committee for Genetic Metabolic Diseases – Could This Be an Opportunity to Support Rare Disease Product Development More Broadly?

FDA Law Blog

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. Note that FDA is currently soliciting applications to staff this committee.

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A prophylactic treatment for hemophilia that you should know about

PEMBlog

Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors. Rather, it can change the bleeding phenotype from severe hemophilia to mild hemophilia – thus potentially reducing the risk of complications. Patients on emicizumab will have it listed on their medication list.

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Rethinking Opioid Conversions: Mary Lynn McPherson and Drew Rosielle

GeriPal

I think part of it’s the math, but I think what really happened is, I think the story here is that in 2018, MD Anderson published this really landmark study by Dr. Reddy and her colleagues about going from IV Dilaudid to other to oral Dilaudid, oral hydromorphone, I should say, oral morphine and oral oxycodone. The old table, 1.5

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Diabetes in Late Life: Nadine Carter, Tamryn Gray, Alex Lee

GeriPal

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. How high is too high?

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

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne 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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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. If they’re in a major car crash, they’re going to have more long-term complications probably than a 20-year-old would. That’s where it really gets to this individual risks and balances, individual situation.

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