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| http://dx.doi.org/10.1016/j.ijsu.2022.106971 | DOI Listing |
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Post-marketing safety concerns with lecanemab: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.
Alzheimers Res Ther
January 2025
Department of Pharmacy, Xuanwu Hospital of Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, 100053, People's Republic of China.
Background: The safety data of lecanemab in the post-marketing period has yet to be fully investigated in the current literature. We aimed to identify and characterise the safety profile of lecanemab in the post-marketing period.
Methods: We searched and reviewed the reports submitted to the FDA's Adverse Event Reporting System (FAERS).
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 PDFPerceptions and intentions regarding IQOS among current US adults who use cigarettes and/or electronic nicotine delivery systems.
Tob Control
December 2024
School of Public Health, Georgia State University, Atlanta, Georgia, USA.
Introduction: IQOS was sold in the US in 2019-2021 and will likely return in 2024. It is important to anticipate IQOS' market penetration; thus, this study examined US adults' prior awareness and perceptions, intentions to try and reactions to an IQOS reduced-risk exposure statement.
Methods: 61 adults from three US cities were recruited to represent four tobacco use subgroups: current cigarette and never electronic nicotine delivery systems (ENDS) use; current cigarette and discontinued ENDS use; current cigarette and ENDS use; and former cigarette use and switched to ENDS.
Developing a Charlson Comorbidity Index for the American Indian Population Using the Epidemiologic Data from the Strong Heart Study.
J Racial Ethn Health Disparities
December 2024
Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Background: The Charlson Comorbidity Index (CCI) is a frequently used mortality predictor based on a scoring system for the number and type of patient comorbidities health researchers have used since the late 1980s. The initial purpose of the CCI was to classify comorbid conditions, which could alter the risk of patient mortality within a 1-year time frame. However, the CCI may not accurately reflect risk among American Indians because they are a small proportion of the US population and possibly lack representation in the original patient cohort.
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