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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Lastly, the reforms enacted by FDORA required that FDA publish guidance on early consultation with FDA to identify novel surrogate or intermediate clinical endpoints, use of novel trials designs for postapproval studies, the expedited withdrawal procedures, and considerations related to the use of surrogate and intermediate clinical endpoints.

Clinic 64
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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

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Transgender Health, Aging, and Advocacy: A Podcast with Noelle Marie Javier and Jace Flatt

GeriPal

Just today (June 17th) as we record this podcast: Ezra Klein released a wonderful interview with Sarah McBride , the first openly transgender member of congress A judge ruled that cuts to NIH grants focused on minority groups, including transgender people, were illegal and ordered the government to restore funding. Can you tell me about that?

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Improving Nursing Home Quality: Jasmine Travers, Alice Bonner, Isaac Longobardi, and Mike Wasserman

GeriPal

Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. Jasmine: It’s an imaginative love story that deconstructs age through an intergenerational friend relationship. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right.

Finance 95
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Palliative Care in India: M.R. Rajagopal

GeriPal

Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. Community-based palliative care networks . Raj’s reflections on the state of palliative care in the US. Transcript.

Community 115
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PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

By the time he got into us, the tumor grew, he had experienced, he was experiencing significant pain and so trauma, informed care and building a relationship with him was such a big part of the care. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes it rewarding? Naheed 03:48 Yeah, for sure.

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The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

I initially got into it because I was really looking at the psychophysiology of stress, and so how stress affects our health and how relationships were always a component of that. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Was hoping to hear Hey, Ya by OutKast. Alex: Great. All right.

IT 99