Results 71 to 80 of about 5,950 (190)

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

open access: yes, 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

The Viloxazine Paradox: A Noradrenergic Agent's Journey From Antidepressant Obscurity to ADHD Precision Therapy

open access: yesCNS Neuroscience &Therapeutics, Volume 32, Issue 4, April 2026.
Viloxazine, a serotonin–norepinephrine modulating agent, has been repurposed from an antidepressant to a novel non‐stimulant for ADHD. Its multimodal mechanism and Phase II/III trials demonstrate clinically meaningful symptom reduction with a distinct safety and interaction profile, offering an alternative for patients who cannot tolerate stimulants ...
Ghaith K. Mansour   +4 more
wiley   +1 more source

Identifying High‐Risk Medications for Drug‐Induced Dystonia: A 20‐Year Retrospective Real‐World Pharmacovigilance Study Based on FAERS

open access: yesHealth Science Reports, Volume 9, Issue 4, April 2026.
ABSTRACT Background and Aims Drug‐induced dystonia is a serious, potentially disabling adverse event (AE) associated with certain medications. Despite its clinical relevance, the existing literature is largely limited to case reports or analyses of individual drugs, and a systematic evaluation of medications implicated in dystonia remains lacking. This
Chunhua Chen   +6 more
wiley   +1 more source

Development of instrument to report and assess causality of adverse events related to herbal medicines

open access: yesVitae
: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment.
Patrícia de Carvalho Mastroianni   +3 more
doaj   +1 more source

PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE [PDF]

open access: yes, 2012
Objectives:High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US ...
Abrishami, P.   +12 more
core   +1 more source

Reshaping study design for faster extrapolation‐based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN–NASPGHAN position paper

open access: yesJournal of Pediatric Gastroenterology and Nutrition, Volume 82, Issue 3, Page 867-894, March 2026.
Abstract Children with inflammatory bowel diseases (IBD) have limited access to the available advanced therapies, given the lengthy gap between adult and pediatric approval. We aimed to review key hurdles for pediatric trials and recommend practical solutions.
Dan Turner   +21 more
wiley   +1 more source

Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização Vigilancia de eventos adversos post vacunación y seguridad de programas de inmunización Surveillance of adverse effects following vaccination and safety of immunization programs

open access: yesRevista de Saúde Pública, 2011
O objetivo da revisão foi analisar aspectos conceituais e operacionais de sistemas de vigilância de eventos adversos pós-vacina. Foram incluídos artigos disponíveis em formato eletrônico, publicados entre 1985 e 2009, selecionados nas bases Medline ...
Eliseu Alves Waldman   +3 more
doaj   +1 more source

Proton-pump inhibitor use is associated with a broad spectrum of neurological adverse events including impaired hearing, vision, and memory. [PDF]

open access: yes, 2019
Proton-pump inhibitors, PPIs, are considered effective therapy for stomach acid suppression due to their irreversible inhibition of the hydrogen/potassium pump in the gastric parietal cells. They are widely prescribed and are considered safe for over-the-
Abagyan, Ruben   +4 more
core   +1 more source

Squamous-cell carcinoma of the tongue following therapy of rheumatoid arthritis with abatacept [PDF]

open access: yes, 2014
A patient affected by rheumatoid arthritis developed a squamous-cell carcinoma probably due to abatacept, according to Naranjo algorithm. The case describes this adverse reaction for the first time and highlights the need for additional studies to ...
Deidda, Arianna   +7 more
core   +1 more source

Bacteriophage Therapy: Current Strategies and Future Perspectives

open access: yesMedComm, Volume 7, Issue 3, March 2026.
This manuscript systematically reviews the expanding scope of phage applications. It moves beyond traditional antibacterial use to explore their role in precision therapies against drug‐resistant infections, their synergy with antibiotics, and advanced biomaterial‐assisted delivery systems.
Zihe Zhou   +7 more
wiley   +1 more source

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