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FDA Guidance Outlines a Framework for the Evaluation of Long-Term Neurodevelopmental Safety Studies in Neonatal Product Development

FDA Law

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). When a comprehensive neurodevelopmental evaluation is needed, it should include an evaluation of physical, mental, and social health.

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Updates in ID and Nephrology: Lona Mody, Rasheeda Hall, Devika Nair, Sonali Advani

GeriPal

We have a discussion about the decision to remove race, a social construct, from clinical risk calculators (though I’m not 100% sold that race should always be removed – if removal is likely to worsen disparities for example – at least until a superior race-blind calculator can be developed). difficile infections.

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Scope This! A Podcast on Gastroesophageal Reflux and Gastritis

PEMBlog

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Now, in the pediatric emergency department, the diagnosis of reflux is primarily clinical. This measures both acid and non acid reflux events.

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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And one person even called the system 75 times and that was just a light-bulb event for me. laughter] Carmen, welcome to the GeriPal podcast!

Community 114
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Palliative Care in Liver Disease: A Podcast with Kirsten Engel, Sarah Gillespie-Heyman, Brittany Waterman, & Amy Johnson

GeriPal

Can you come and be in our clinic once a week? It used to also be a social worker and myself who would actually go to clinic and spend some time up there. Eric 07:08 Which of the patients that you think you’re helpful for, you want referrals? I started our liver embedded liver clinic about seven and a half years ago.

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Demystifying the Role of HHS and ASPE in Guiding Federal Aging Policy and Priorities with Dr. Tisamarie Sherry

GeriPal

There’s the complications associated with immune senescence, comorbidities, atypical clinical presentations. And I think that’s where this clinical trial which looked at seven versus 14 days was really practice-changing for many of us. difficile infections. difficile that patients are exposed to and antibiotic resistance.

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Guidelines or Goals in Heart Failure: A Podcast with Parag Goyal, Nicole Superville, and Matthew Shuster

GeriPal

He’s a medical director of H ebrew S enior L ife outpatient clinic at Newbridge. Alex 04:07 A heart failure clinic playing in the background. If they’re frail, if they’re falling, if they have cognitive impairment, they’re at higher risk of adverse drug events. He’s in Boston. Eric 14:10 Yeah.