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. When the U.S.

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Provider IT Consulting Medical 59

Today's Hospitalist

MAY 9, 2025

Looking ahead, here are several emerging innovations that promise to shape the next generation of these tools: Deeper integration with hospitalist workflow: Initiating an AI-assisted note may soon be as effortless as speaking naturally during a patient consult—no disruptions, no clicks. References: 1. Shanafelt TD, West CP, Sinsky C, et al.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 52

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

The record also does not reflect consultation with the requisite experts, and FDA ignored some of the risks associated with elevated sodium intake, which is precisely the benefit provided by Xywav. Jazz believes that FDA precedent precludes that position and thus FDA departed from established policy, which FDA denied ever existed.

Clinic 52

Clinic Provider IT Patients 52

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. So those questions we ask when we’re doing a palliative care consult. Or volunteers, we have volunteers on our palliative care team that are doing story catching, not in my research project because I don’t have persons who are receiving formal palliative care consults.

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Patient-Centered Illness Healthcare IT 115

GeriPal

DECEMBER 15, 2022

So those questions we ask when we’re doing a palliative care consult. Or volunteers, we have volunteers on our palliative care team that are doing story catching, not in my research project because I don’t have persons who are receiving formal palliative care consults. We need to remedy that issue, Eric.

IT 105

IT Patient-Centered Healthcare Illness 105

GeriPal

JANUARY 16, 2025

Eric 13:00 I also love that too, because even on our inpatient ballot of care consult service, whenever somebody says that they’re unrepresented or they don’t have a surrogate, we never believe that until we usually look up. You know, baby boomer generation started to turn 65 and older back in 2011.

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Patient-Centered IT Patients Healthcare 109