FDA Law

JANUARY 12, 2025

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

Clinic Relationship Provider IT 64

GeriPal

FEBRUARY 2, 2024

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.

Consulting 120

Consulting Hospital Patient-Centered IT 120

GeriPal

APRIL 10, 2025

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.

Patient-Centered 77

Patient-Centered Hospital IT Patients 77

GeriPal

MARCH 6, 2025

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.

Healthcare 100

Healthcare IT Community Illness 100