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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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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Demystifying the Role of HHS and ASPE in Guiding Federal Aging Policy and Priorities with Dr. Tisamarie Sherry

GeriPal

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. So NIA and further funded this coordinating center that we call Clin-STAR.

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Allowing Patients to Die: Louise Aronson and Bill Andereck

GeriPal

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985.

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Health and Wealth Shocks: Lauren Hunt, Rebecca Rodin, Tsai-Chin Cho

GeriPal

Those disruptive events or shocks often portend a major decline in function from which people with dementia never fully recover. Today we talk about disruptive events, or health and wealth shocks. Wait, so one key message is that social health is linked to physical and cognitive health?!? What’s a disruptive event?

Illness 93
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PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

And this is really traumatic event for his street family and the street community that he knew. They’re more, more interested in relationship centered care than the fancy medicines that you’re. And I wonder if that is key in patients, people who are experiencing homelessness as well. Government is not the 51st state.

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. And that’s a good thing to share with an older patient or client that making decisions about your activity.