Results 21 to 30 of about 787,943 (334)

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

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

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

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

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

Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine

Journal of the American Veterinary Medical Association, 2004
Victoria A, Hampshire, Frederick M, Doddy, Lynn O, Post, Teresa L, Koogler, Tina M, Burgess, Priscilla O, Batten, Roderick, Hudson, Dorothy R, McAdams, Margarita A, Brown   +8 more
openaire   +3 more sources

Systems validation: application to statistical programs [PDF]

, 2005
BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which ...
D Moher, FDA, FDA, Rickey E Carter, T Stokes, T Stokes   +5 more
core   +3 more sources

Recalls of tattoo and permanent makeup inks in the United States and a follow-up microbiological survey of inks with a previous recall history

Frontiers in Public Health, 2023
In this study, we collected voluntary recall records of tattoo and permanent makeup ink from the U.S. Food and Drug Administration (US FDA) Enforcement Report Database. The recall records contain information, such as recall date, manufacturer, ink color,
Sunghyun Yoon, Sandeep Kondakala, Mi Sun Moon, Mei-Chiung J. Huang, Goran Periz, Steven L. Foley, Ohgew Kweon, Seong-Jae Kim   +7 more
doaj   +1 more source

Burn injuries related to E-cigarettes reported to poison control centers in the United States, 2010–2019

Injury Epidemiology, 2020
Background United States (U.S.) national data indicate that 2035 individuals with burn injuries from e-cigarette explosions presented to U.S. hospital emergency departments (EDs) in 2015–2017.
Baoguang Wang, Sherry T. Liu, Brian Rostron, Camille Hayslett   +3 more
doaj   +1 more source