Results 91 to 100 of about 471,442 (349)

A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]

, 2007
This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core   +1 more source

Peripheral blood proteome biomarkers distinguish immunosuppressive features of cancer progression

Molecular Oncology, EarlyView.
Immune status significantly influences cancer progression. This study used plasma proteomics to analyze benign 67NR and malignant 4T1 breast tumor models at early and late tumor stages. Immune‐related proteins–osteopontin (Spp1), lactotransferrin (Ltf), calreticulin (Calr) and peroxiredoxin 2 (Prdx2)–were associated with systemic myeloid‐derived ...
Yeon Ji Park, Jae Won Oh, Hyewon Chung, Jung Won Kwon, Yi Rang Na, Kwang Pyo Kim, Seung Hyeok Seok   +6 more
wiley   +1 more source

A transient inflammatory response contributes to oxaliplatin neurotoxicity in mice

Annals of Clinical and Translational Neurology, Volume 9, Issue 12, Page 1985-1998, December 2022., 2022
Abstract Objectives Peripheral neuropathy is a relevant dose‐limiting adverse event that can affect up to 90% of oncologic patients with colorectal cancer receiving oxaliplatin treatment. The severity of neurotoxicity often leads to dose reduction or even premature cessation of chemotherapy.
Aina Calls, Abel Torres‐Espin, Marc Tormo, Laura Martínez‐Escardó, Núria Bonet, Ferran Casals, Xavier Navarro, Víctor J. Yuste, Esther Udina, Jordi Bruna   +9 more
wiley   +1 more source

Uso de medicamentos off-label e não licenciados em unidade de tratamento intensivo neonatal e sua associação com escores de gravidade Use of off-label and unlicensed drugs in the neonatal intensive care unit and its association with severity scores

Jornal de Pediatria, 2012
OBJETIVO: Avaliar a frequência da prescrição de medicamentos de uso não licenciado (UL) e off-label (OL) em recém-nascidos internados em unidade de tratamento intensivo neonatal de hospital de nível terciário e verificar a associação do seu uso com a ...
Clarissa G. Carvalho, Mariana R. Ribeiro, Mariana M. Bonilha, Mauro Fernandes Jr, Renato S. Procianoy, Rita C. Silveira   +5 more
doaj  

Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes

SAGE Open Medicine, 2017
Background: Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm.
Jessica L Norman, Danielle R Fixen, Joseph J Saseen, Laura M Saba, Sunny A Linnebur   +4 more
doaj   +1 more source

The Battle over Implied Preemption: Products Liability and the FDA [PDF]

, 2007
A mere five years ago, the Food and Drug Administration (the FDA ) began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law ...
Davis, Mary J
core   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

TOMM20 as a driver of cancer aggressiveness via oxidative phosphorylation, maintenance of a reduced state, and resistance to apoptosis

Molecular Oncology, EarlyView.
TOMM20 increases cancer aggressiveness by maintaining a reduced state with increased NADH and NADPH levels, oxidative phosphorylation (OXPHOS), and apoptosis resistance while reducing reactive oxygen species (ROS) levels. Conversely, CRISPR‐Cas9 knockdown of TOMM20 alters these cancer‐aggressive traits.
Ranakul Islam, Megan E. Roche, Zhao Lin, Diana Whitaker‐Menezes, Victor Diaz‐Barros, Eurico Serrano, Maria Paula Martinez Cantarin, Nancy J. Philp, Atrayee Basu Mallick, Ubaldo Martinez‐Outschoorn   +9 more
wiley   +1 more source

The anterior nucleus of the thalamus plays a role in the epileptic network

Annals of Clinical and Translational Neurology, Volume 9, Issue 12, Page 2010-2024, December 2022., 2022
Abstract Objectives We investigated both the metabolic differences and interictal/ictal discharges of the anterior nucleus of the thalamus (ANT) in patients with epilepsy to clarify the relationship between the ANT and the epileptic network. Methods Nineteen patients with drug‐resistant epilepsy who underwent stereoelectroencephalography were studied ...
Hao Yan, Xueyuan Wang, Tao Yu, Duanyu Ni, Liang Qiao, Xiaohua Zhang, Cuiping Xu, Wei Shu, Yuping Wang, Liankun Ren   +9 more
wiley   +1 more source

Automatic text classification of drug-induced liver injury using document-term matrix and XGBoost

Frontiers in Artificial Intelligence
IntroductionRegulatory agencies generate a vast amount of textual data in the review process. For example, drug labeling serves as a valuable resource for regulatory agencies, such as U.S. Food and Drug Administration (FDA) and Europe Medical Agency (EMA)
Minjun Chen, Yue Wu, Byron Wingerd, Zhichao Liu, Joshua Xu, Shraddha Thakkar, Thomas J. Pedersen, Tom Donnelly, Nicholas Mann, Weida Tong, Russell D. Wolfinger, Wenjun Bao   +11 more
doaj   +1 more source