Cronobacter (C.) sakazakii is an opportunistic pathogen and has been associated with serious infections with high mortality rates predominantly in pre-term, low-birth weight and/or immune compromised neonates and infants.
Hannah R. Chase +14 more
doaj +1 more source
Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine [PDF]
Victoria Hampshire +8 more
openalex +3 more sources
Is Simpler Always Better? Consumer Evaluations of Front-of-Package Nutrition Symbols [PDF]
Consumers of packaged goods products in the United States recently have faced an onslaught of front-of-package (FOP) nutrition symbols and icons, including the controversial “Smart Choices” single summary indicator.
Andrews, J. Craig +2 more
core +3 more sources
Resolution of the Portunus gladiator species complex: taxonomic status and identity of Monomia gladiator (Fabricius, 1798) and Monomia haanii (Stimpson, 1858) (Brachyura, Decapoda, Portunidae) [PDF]
The United States Food and Drug Administration (FDA) has recently adopted DNA barcoding for the purpose of determining the species identity of commercial seafood products.
Amanda M. Windsor +2 more
doaj +3 more sources
FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
This paper describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a drug product; 2) establish ...
Lawrence X. Yu +5 more
doaj +1 more source
Microbiomes Associated With Foods From Plant and Animal Sources
Food microbiome composition impacts food safety and quality. The resident microbiota of many food products is influenced throughout the farm to fork continuum by farming practices, environmental factors, and food manufacturing and processing procedures ...
Karen G. Jarvis +8 more
doaj +1 more source
Introduction: The Food and Drug Administration Center for Biologics Evaluation and Research conducts post-market surveillance of biologic products to ensure their safety and effectiveness.
Matthew Deady +9 more
doaj +1 more source
Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]
This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges.
Hamill, P.A., McIlkenny, P., Opong, K.K.
core +1 more source
Artificial intelligence (AI) has played a crucial role in advancing biomedical sciences but has yet to have the impact it merits in regulatory science. As the field advances, in silico and in vitro approaches have been evaluated as alternatives to animal
Skylar Connor +6 more
doaj +1 more source
Prevalence of Antimicrobial Resistance in Select Bacteria From Retail Seafood—United States, 2019
In 2019, the United States National Antimicrobial Resistance Monitoring System (NARMS) surveyed raw salmon, shrimp, and tilapia from retail grocery outlets in eight states to assess the prevalence of bacterial contamination and antimicrobial resistance ...
Heather Tate +19 more
doaj +1 more source

