Results 81 to 90 of about 6,056 (173)

Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices [PDF]

, 2011
Objective: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices.
Brennan, Troyen Anthony, Liang, Matthew Heng, Mahomed, Nizar N, Sledge, Clement Blount, Syed, Khalid   +4 more
core   +1 more source

Recurrent fexuprazan‐induced liver injury following unintentional re‐exposure

British Journal of Clinical Pharmacology, Volume 91, Issue 11, Page 3266-3271, November 2025.
Fexuprazan, a potassium‐competitive acid blocker, is increasingly used for the treatment of gastroesophageal reflux disease in South Korea. While generally well tolerated, data regarding its hepatotoxic potential are scarce. We report a case of idiosyncratic drug‐induced liver injury in a 61‐year‐old woman following 2 months of fexuprazan therapy.
Sook Jin Seong, O Seong Kweon, Young‐Ran Yoon, Yu Kyung Kim, Yoo Na Kang, Se Young Jang   +5 more
wiley   +1 more source

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

Avaliação do sistema brasileiro de vigilância de eventos adversos pós-vacinação Evaluation of the Brazilian surveillance system for adverse events following vaccination

Revista Brasileira de Epidemiologia, 2011
OBJETIVOS: Descrever e avaliar o Sistema brasileiro de vigilância passiva de eventos adversos pós-vacinação (SPVEAPV). MÉTODOS: A descrição e avaliação do SPVEAPV fundamentaram-se nas notificações de eventos adversos pós-vacina Tetravalente ou DTwP/Hib -
Sandra Aparecida Moreira Gomes Monteiro, Olga Akiko Takano, Eliseu Alves Waldman   +2 more
doaj   +1 more source

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

, 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., Flamion, B., Garattini, S., Huic, M., Hulstaert, F., Kuijpers, M. R., Neyt, M., Pavlovic, M., Sauerland, S., Stordeur, S., van Brabandt, H., Vinck, I., Vondeling, H.   +12 more
core   +1 more source

Pulmonary Hypertension and Other Potentially Fatal Pulmonary Complications in Systemic Juvenile Idiopathic Arthritis [PDF]

, 2012
Objective Systemic juvenile idiopathic arthritis (JIA) is characterized by fevers, rash, and arthritis, for which interleukin‐1 (IL‐1) and IL‐6 inhibitors appear to be effective treatments.
Carol A. Wallace, Egla Rabinovich, Elizabeth Kessler, Jennifer E. Weiss, Jordi Antón, Karen Onel, Kathryn L. Haroldson, Marilynn Punaro, Melissa M. Hazen, Meredith Riebschleger, Murray H. Passo, Nico Wulffraat, null null, Patricia Woo, Peter R. Blier, Robert M. Rennebohm, Sheila Oliveira, Tzielan Lee, Valeria Gerloni, Yukiko Kimura   +19 more
core   +1 more source

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

Vitae
: 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, Fabiana Rossi Varallo, Marília Amaral Costa, Luis Vitor da Silva Sacramento   +3 more
doaj   +1 more source

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]

, 2018
Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D, Ferrell, Andrea, Hsiung, Andre, Humphries, Romney M, Kircher, Susan, Krause, Kevin M, Malherbe, Rianna   +6 more
core   +2 more sources

FDA‐Approved Biologics for CRSwNP: A Five‐Year Analysis of the FDA Adverse Event Reporting System

Laryngoscope Investigative Otolaryngology, Volume 10, Issue 5, October 2025.
Biologics are increasingly utilized in the treatment of chronic rhinosinusitis with nasal polyps. In this study, we characterized the adverse events reported in the FDA adverse event reporting system associated with each biologic to better understand who is at greatest risk for a serious adverse event.
Radhika Duggal, Mohamad R. Chaaban
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

Revista 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, Karin Regina Luhm, Sandra Aparecida Moreira Gomes Monteiro, Fabiana Ramos Martin de Freitas   +3 more
doaj   +1 more source