article thumbnail

Risking It All For a New Business Model at Family Physicians of St. Joe

Family Physicians of St. Joseph

Larger companies now dominate the healthcare landscape, yet through innovation and a dedication to exceptional patient care, Family Physicians of St. They have remained independent and committed to caring for patients as a small practice, all the while introducing new ideas and setting new standards in Michigan’s Great Southwest.

article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

article thumbnail

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

GeriPal

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. Panelists Kate Courtright and Scott Halpern have no relationships to disclose. And PAIR stands for the Palliative and Advanced Illness Research Center.

article thumbnail

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.

Provider 119
article thumbnail

Hastening Death by Stopping Eating and Drinking: Hope Wechkin, Thaddeus Pope, & Josh Briscoe

GeriPal

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

IT 89
article thumbnail

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?

IT 118