FDA Law

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Physician's Weekly

JUNE 14, 2025

The following is a summary of “PLASMIC score to aid diagnosis of aHUS: an analysis of C5 inhibitor clinical trials and the PINC AI™ healthcare database,” published in the May 2025 issue of BMC Nephrology by Uriol-Rivera et al. Around 85% had scores ≤ 5 (range: 3–5), with similar distribution across trials. for detecting probable aHUS.

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Clinic Individual Healthcare Utilities 52

Physician's Weekly

JUNE 22, 2025

High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice. A greater social risk burden was linked to increased odds of unplanned healthcare utilization (severe vs none: OR, 3.5 [1.2-10.2])

Healthcare 52

Healthcare Transportation IT Insurance 52

Physician's Weekly

JUNE 22, 2025

Males had higher levels of urinary mast cell mediators—LTE4, 2,3-BPG, and tryptase—particularly in atopic individuals, compared to females. These sex-based differences suggest the need to account for sex in interpreting diagnostic biomarkers for mast cell and atopic disorders.

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Asthma Utilities Clinic Individual 52

The Physicians Foundation

MAY 20, 2025

The Physicians Foundation announces the 2025 recipient of the Drivers of Health (DOH) Fellowship Program, urges physicians to screen patients for DOH BOSTON, May 21, 2025 – Today, The Physicians Foundation reinforces its efforts to help physicians address drivers of health (DOH) to improve a person’s overall health.

Chronic Disease 40

Chronic Disease Screening Transportation Patient-Centered 40

FDA Law

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinic 59

Clinic Provider Individual IT 59

GeriPal

APRIL 10, 2025

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a clinical decision support? Long overdue.

Patient-Centered 77

Patient-Centered Hospital IT Patients 77

GeriPal

FEBRUARY 13, 2025

And so we worked closely with a community advisory group who, through focus groups, told us how it was that black and white individuals with serious illness had wanted to be treated. The black individuals wanted to have a separate one from the white individuals. And resource utilization was very low in all the groups.

Consulting 63

Consulting Community Patient-Centered Family 63

GeriPal

JUNE 26, 2025

But from our clinical work, many of us are familiar with people with dementia who experience sudden shocks to their health, think hip fracture, think hospitalization for pneumonia. Sometimes people call them health shocks, but we kind of all, like, clinically, intuitively know what these things are. Has really changed.

Illness 93

Illness Hospital IT Patient-Centered 93

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. And they can start July of 2025.

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Patient-Centered IT Family Families 125

Doctors for America

APRIL 29, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 April 29, 2025 FDA Task Force Statement on President Trump’s First 100 Days in Office WASHINGTON, D.C. We hope that Commissioner Makary will utilize his experience to help ensure FDA puts patients over politics throughout his tenure.

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