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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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RCT of Default Inpatient PC Consults: Kate Courtright & Scott Halpern

GeriPal

This week, we talk about the other major palliative care trial of default palliative care consults for hospitalized older adults with COPD, kidney disease, or dementia, published in the same issue of JAMA. Panelists Kate Courtright and Scott Halpern have no relationships to disclose. and consulting for Papa Health.

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End-of-Life Doulas: A Podcast with Jane Euler, Beth Klint, and John Loughnane

GeriPal

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. There’s an organization that I took my training from, which began, I want to say, in 2012.

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Optimizing Nutrition in Aging: A Podcast with Anna Pleet, Elizabeth Eckstrom, and Emily Johnston

GeriPal

Widera and Smith have no relationships to disclose. Guests Anna Pleet, Elizabeth Eckstrom, and Emily Johnston have no relationships to disclose. And I think that’s something that we can really focus on, especially with geriatric patients. And when you tell your patients that, they’re like, what?

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