Remove 2023 Remove Consulting Remove IT Remove Patient-Centered
article thumbnail

Using technology to reclaim our time

Today's Hospitalist

For many of us, the emergence of medical scribes, both in-person and remote, provided a valuable solution, offloading documentation and allowing us to have more focused patient interactions. It can differentiate between a physician’s questions and a patient’s responses and even filter out non-relevant small talk.

article thumbnail

From Surgeries To Keeping Company: The Place Of Robots In Healthcare

The Medical Futurist

Robotic nurses dressing mannequins and bed-bathing patients Delicate movement, like gently handling an elderly patient is traditionally the most challenging task to robots, who are much faster developing in intellectual tasks than matching humans in fine-motor skills. But there is undoubtedly impressive progress.

Insiders

Sign Up for our Newsletter

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

article thumbnail

While the Orphan Battles Wages, Jazz Takes a Loss

FDA Law Blog

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. This case followed. The Court held that it does.

Clinic 111
article thumbnail

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

article thumbnail

FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law Blog

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

article thumbnail

Should you have a coach? Greg Pawlson, Beth Griffiths, & Vicky Tang

GeriPal

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

article thumbnail

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.