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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

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).

Clinic 64
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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. Scott: Yes.

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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. Naheed 15:56 2014. Eric 15:57 2014. I’m guessing, like here, especially in 2014, almost none of it was. Yeah, yeah.

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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

I think that study was really important, especially I think the message that I give people is you can do something as simple as calling a consultation and improve quality of life months later. Eric 26:01 Curtis’s, he had a 2014 JAMA article on simulation. So that’s great. Basically vital talk. No difference. Absolutely.