Results 51 to 60 of about 756,003 (352)

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]

ZooKeys, 2019
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, Jose Christopher E. Mendoza, Jonathan R. Deeds   +2 more
doaj   +3 more sources

Microbiomes Associated With Foods From Plant and Animal Sources

Frontiers in Microbiology, 2018
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, Ninalynn Daquigan, James R. White, Paul M. Morin, Laura M. Howard, Julia E. Manetas, Andrea Ottesen, Padmini Ramachandran, Christopher J. Grim   +8 more
doaj   +1 more source

The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing

Frontiers in Digital Health, 2021
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, Hussein Ezzeldin, Kerry Cook, Douglas Billings, Jeno Pizarro, Amalia A. Plotogea, Patrick Saunders-Hastings, Artur Belov, Barbee I. Whitaker, Steven A. Anderson   +9 more
doaj   +1 more source

Food and drug administration approval process for dermatology drugs in the United States

Journal of Dermatological Treatment, 2018
The purpose of this review is to elucidate the steps involved in the FDA's approval of new dermatology drugs.To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals).In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three ...
Emily Boozalis, Yevgeniy R. Semenov, Shawn G. Kwatra   +2 more
openaire   +3 more sources

FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

International Journal of Pharmaceutics: X, 2019
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, Andre Raw, Larisa Wu, Christina Capacci-Daniel, Ying Zhang, Susan Rosencrance   +5 more
doaj   +1 more source

Adaptability of AI for safety evaluation in regulatory science: A case study of drug-induced liver injury

Frontiers in Artificial Intelligence, 2022
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, Ting Li, Ruth Roberts, Ruth Roberts, Shraddha Thakkar, Zhichao Liu, Weida Tong   +6 more
doaj   +1 more source

Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]

, 2013
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

Prevalence of Antimicrobial Resistance in Select Bacteria From Retail Seafood—United States, 2019

Frontiers in Microbiology, 2022
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, Sherry Ayers, Epiphanie Nyirabahizi, Cong Li, Stacey Borenstein, Shenia Young, Crystal Rice-Trujillo, Sanchez Saint Fleurant, Sonya Bodeis-Jones, Xunde Li, Melissa Tobin-D’Angelo, Victoriya Volkova, Rachel Hardy, Lisa Mingle, Nkuchia M. M’ikanatha, Laura Ruesch, Chris A. Whitehouse, Gregory H. Tyson, Errol Strain, Patrick F. McDermott   +19 more
doaj   +1 more source

The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010

Drug Safety, 2014
BackgroundThe United States Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs.
Keith Hoffman, M. Dimbil, Colin B. Erdman, N. Tatonetti, Brian M. Overstreet   +4 more
semanticscholar   +1 more source

An Overview of Foodborne Sample-Initiated Retrospective Outbreak Investigations and Interagency Collaboration in the United States

Journal of Food Protection, 2023
Foodborne outbreak investigations have traditionally included the detection of a cluster of illnesses first, followed by an epidemiologic investigation to identify a food of interest.
Allison Wellman, Michael C Bazaco, Tyann Blessington, Arthur Pightling, Asha Dwarka, Leslie Hintz, Matthew E. Wise, Laura Gieraltowski, Amanda Conrad, Thai-An Nguyen, Kelley Hise, Stelios Viazis, Jennifer Beal   +12 more
doaj   +1 more source