Results 71 to 80 of about 5,950 (190)
A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]
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
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
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
: 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]
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
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
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]
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]
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
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

