Today's Hospitalist

MAY 9, 2025

We have seen explosive growth and become a cornerstone of modern health care systems. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation. Documentation isn’t just time-consuming; it also contributes to pervasive physician burnout. It’s about augmenting your capabilities.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

FDA Law Blog

AUGUST 12, 2024

Patent and Trademark Office consulted with FDA on the appropriate timelines, FDA claimed that the INAD, and thereby the testing phase, was not effective until August 4, 2011 because no NCIE was submitted until then. Thus, the Agency concluded, the June 2011 date should stand. FDA’s PTE regulations at 21 C.F.R. When the U.S.

Provider 59

Provider IT Consulting Medical 59

FDA Law Blog

JANUARY 4, 2023

The Agency referred to its 2011 FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products during the town hall. Per the 2011 FDA Guidance, developers should validate the assay prior to conducting a clinical study that will investigate the efficacy for licensure. Comparability.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law Blog

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

Clinic 52

Clinic Provider IT Patients 52

GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. Because that really is what this is about. SPONSOR: .

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

GeriPal

JANUARY 16, 2025

We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions. Alex 02:21 For Eric 02:21 For unrepresented older adults. But before we go into that topic, Tim, I think you have a song request. Tim 02:29 Yeah, it’s such an honor to make a song request. Can you guys do that one?

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109