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Transition Plans for Covid-19 Products are Amongst CDRH FY2023 Priorities

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. The 2013 guidance documents include, but are not limited to, in vitro diagnostic and clinical trial considerations.

Medical 52
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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. There are hundreds of known genetic metabolic diseases, most of which are rare and carry significant morbidity.

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Improving Hospital Care for Older Adults through Acute Care for Elders (ACE Units): Kellie Flood and Stephanie Rogers

GeriPal

Alex: And we’re delighted to welcome back to the GeriPal Podcast, Stephanie Rogers, who’s a geriatrician and medical director of UCSF’s, age-friendly health systems. JAMA IM 2013, you had a paper that showed what, 300, $400. Kellie, welcome to the GeriPal Podcast. Kellie: Thank you so much. Great to be here.

Hospital 100
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Scope This! A Podcast on Gastroesophageal Reflux and Gastritis

PEMBlog

2013-0421 Tighe M, Afzal NA, Bevan A, et al. Red flags that you should always ask about include hematemesis, melana, dysphagia, and Unintentional weight loss, these all need further investigation for complications like esophagitis or another diagnosis such as EOE or peptic ulcer disease. J Pediatr Gastroenterol Nutr. doi: 10.1097/MPG.0000000000001889

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Aging and the ICU: Podcast with Lauren Ferrante and Julien Cobert

GeriPal

Eric: I got a question because it was a ways back, but we did a podcast on keep your hands to yourself from a JAMA IMR article that showed that use of mechanical ventilation for nursing home residents with advanced dementia doubled between 2000 and 2013, that was a John Tino study. I think it’s really, really complicated.

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What is Death? Winston Chiong and Sean Aas

GeriPal

And for all the ways in which every single case of brain death is so complicated, you might step back and say that brain death is working out okay in the real world, right? Winston 33:31 2013. There’s disagreement within, some medical associations are against this. Eric 33:27 Are outliers, like, most of the time.

IT 113
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What We Now Know About COVID Prevention and Treatment: A Podcast with Monica Gandhi

GeriPal

And to be very fair, there was a study in 2013 in family practice, this would be important, I think for those who treat older patients. And all these tools I’m mentioning to you are medical. And one in five people had a serious COVID complication. Oseltamivir isn’t that great. So let me just put it cleanly.