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Defining "High-In" Saturated Fat, Sugar, and Sodium to Help Inform Front-of-Pack Labeling Efforts for Packaged Foods and Beverages in the United States.
Nutrients
December 2024
Carolina Population Center, University of North Carolina, Chapel Hill, NC 27516, USA.
: To help consumers make healthier choices, the US Food and Drug Administration (FDA) has been charged with developing a front-of-package label (FOPL) to appear on US packaged foods and beverages. One option being explored is the use of "high-in" FOPLs for added sugar, sodium, and saturated fat using a threshold of ≥20% of the recommended daily value (%DV) per portion/serving size to define "high-in". While research has addressed what FOPL designs are most effective at visually communicating "high-in", less attention has been paid to the nutrient profile model (NPM) used to decide which products should receive these labels.
View Article and Find Full Text PDFUse of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective.
AAPS PharmSciTech
January 2025
OSIS, Silver Spring, Maryland, U.S.A.
Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration's (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections.
View Article and Find Full Text PDFNavigating regulatory and policy challenges for AI enabled combination devices.
Front Med Technol
November 2024
Advance Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC, United States.
In recent years, the Artificial Intelligence (AI) has enabled conventional Combination Devices (CDs) to innovate in healthcare merging with technology sectors. However, the challenges like reliance on predicate devices in US Food and Drug Administration (FDA's 510(k) pathway, especially for perpetually updating AI are stressed. Though the European Union (EU's new Medical Device Regulations address software and AI, fitting adaptive algorithms into conformity assessments remains difficult.
View Article and Find Full Text PDFCurrent status of fluid biomarkers for early Alzheimer's disease and FDA regulation implications.
J Neurol Sci
December 2024
Department of Bionanotechnology, Bionano Research Institute, Gachon University, 1342 Seongnam-daero, Sujeong-gu, Seongnam-si 13120, Gyeonggi-do, Republic of Korea. Electronic address:
Many changes can now be seen in the development and use of tests, especially those incorporating fluid biomarkers, to diagnose Alzheimer's disease (AD), a devastating disease caused by the progressive but rapid degeneration of cortical tissue. Some biomarkers we already know have a significant association with AD, such as amyloid beta (Aβ) and tau, as well as the ratio of concentrations of other Aβ isoforms. In addition, several novel biomarkers are emerging that can also be used as diagnostic fluid biomarkers for AD, but many studies are still needed before we can consider them reliable.
View Article and Find Full Text PDFPreferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment.
Lancet Oncol
December 2024
Department of Health Policy, London School of Economics and Political Science, London, UK.
Background: The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of new cancer drugs in exchange for faster access is not known. This study aims to examine preferences for access versus certainty, and to understand factors that influence these preferences.
Methods: A US nationally representative sample of older adults were recruited via Cint, an online platform for survey research, to take part in an online discrete choice experiment.
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