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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

Clinic 64
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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. We are not a Monolith.

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Palliative Care in India: M.R. Rajagopal

GeriPal

So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college. But when I retired from government service, I left Kalakkad in 2002. Raj: We are not limited by definitions because we started our first non non-government organization.

Community 115
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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. I know you’ve been a strong advocate for nursing home patients particularly in California. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government.

Finance 95
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When do we learn to treat our doctors properly?

Tiny Physician

Archana Sharma committed suicide because of the harassment by the bystanders of the patient who died at her hospital. She was a post-graduate in Obstetrics and Gynaecology (the branch which covers pregnancy and the female reproductive system) and she had won various accolades during her student and consultant days.

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

GeriPal

But, should we as clinicians care about the social lives of our patients? Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? But then recognizing that our relationships impact our health even outside the context of stress.

IT 99
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What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. Panelists Bill Gardner, Sonu Gaind, Leonie Herx have stated they have no relationships to disclose. AMA PRA Category 1 credit(s) â„¢. Leonie, welcome to GeriPal.

Illness 144