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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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. and consulting for Papa Health. And PAIR stands for the Palliative and Advanced Illness Research Center. Kate: Thank you.

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Medical Cannabis Revisted: A Podcast with David Casarett and Eloise Theisen

GeriPal

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? This is back in, I don’t know, like 2014 maybe. And then one patient who really knew more about a topic than I did, which unfortunately happens much more often.

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

GeriPal

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

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Podcast Episode: Febrile Seizures

PEMBlog

Nat Genet 2014; 46:1274. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. You should develop a specific plan for each patient with each patient. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. A pediatric neurologist.

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