Results 61 to 70 of about 588,781 (167)

Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping review

Frontiers in Medical Technology
IntroductionHigh-risk and innovative medical devices (MDs) and in vitro diagnostic devices (IVDs) in the European Union are subject to increasingly stringent and evolving regulatory requirements.
Nensi Bralić, Ružica Bandić, Miro Vuković, Danira Matijaca, Renata Valsami, Panagiotis Zoumpoulakis, Kalle Schnitzer, Mari Levula, Risto Roine, Antti Viitala, Antti Pihlava, Olivia McDermott, Ana Marušić   +12 more
doaj   +1 more source

Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea

Clinical Ophthalmology, 2021
Gahyung Ryu,1,2 Donghyoun Noh,1,2 Guihyun Moon,3 Min Sagong1,2 1Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 2Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Republic of Korea; 3Bayer Korea Ltd,
Ryu G, Noh D, Moon G, Sagong M
doaj  

Real‐World Safety and Effectiveness of Glatiramer Acetate in Patients With Multiple Sclerosis: Final Results of Post‐Marketing Surveillance in Japan

Neurology and Clinical Neuroscience, Volume 14, Issue 5, Page 386-397, September 2026.
ABSTRACT Background Glatiramer acetate is an injectable disease‐modifying therapy indicated for multiple sclerosis (MS). Aim To evaluate the real‐world safety and effectiveness of glatiramer acetate for MS in Japan. Methods A prospective, multicenter, observational, all‐case post‐marketing survey was conducted in Japan between November 2015 and March ...
Masaaki Niino, Eriko Hayashi, Mai Itani, Jun‐ichi Kira   +3 more
wiley   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, Volume 92, Issue 8, Page 2797-2808, August 2026.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Real-World Safety of Acalabrutinib in Mexico: A Postmarketing Surveillance Study

Pharmacoepidemiology
Background: Acalabrutinib is a selective Bruton tyrosine kinase inhibitor widely used for chronic lymphocytic leukemia and mantle cell lymphoma. Real-world safety evidence from Latin America remains limited, which restricts local benchmarking and ...
Akemi Ishikawa-Ichikawa, Jorge Alberto Islas-Martínez, Eduardo Rios-Garcia, Luis Fernando Tejado-Gallegos, Pamela Monserrat Ramírez-Marín   +4 more
doaj   +1 more source

Beyond the CE Mark: A Call to Action for Minimum CGM Accuracy Standards in Central and Eastern European Nations

Diabetes, Obesity and Metabolism, EarlyView.
Tomasz Klupa, Silvija Canecki‐Varžić, Adriana Ilavská, Andrej Janez, Sanja Klobučar, Mladen Krnić, Tatjana Milenkovic, Peter Novodvorský, Martin Prázný, Marko Simunovic, Jan Šoupal, Anca Pantea Stoian, Agnieszka Szadkowska, Tsvetelina Tankova, Tadej Battelino   +14 more
wiley   +1 more source

HEALTH VALUE IN FOOD SAFETY SURVEILLANCE INITIATIVES [PDF]

Recognizing the increasing concern about the potential health effects of genetically modified foods, this research provides a framework for economic value of monitoring genetically modified food for their potential long-term human health effects. This is
Amanor-Boadu, Vincent, Mowat, David, Boland, Michael A.   +2 more
core  

Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC)

Journal of Blood Medicine, 2019
Madhvi Rajpurkar,1 Stacy E Croteau,2 Lisa Boggio,3 David L Cooper4 1Carman and Ann Adams Department of Pediatrics, Children’s Hospital of Michigan/Wayne State University, Detroit, MI, USA; 2Department of Pediatrics, Boston Children’s Hospital/
Rajpurkar M, Croteau SE, Boggio L, Cooper DL   +3 more
doaj  

A Prospective, Multicenter Study on the Clinical Effectiveness and Safety of Abiraterone Plus Prednisone in Metastatic Hormone-Sensitive Prostate Cancer in Korea: Real-World Data Analysis [PDF]

Journal of Urologic Oncology
Purpose This postmarketing surveillance (PMS) study aimed to evaluate real-world data on the effectiveness and safety of abiraterone acetate plus prednisone (AAP) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Hyomyoung Lee, Seung-hwan Jeong, Sangeun Yeon, Youngdoe Kim, Jaeyoung Joung, Hanjong Ahn, Seongsoo Jeon, Hakmin Lee, Sangchul Lee, Choung-Soo Kim, Cheol Kwak   +10 more
doaj   +1 more source

Facilitating Expedited Drug Approval—the Past, Present, and Future of Clinical Trials for Pediatric Rheumatic Disease

Arthritis Care &Research, Volume 78, Issue 10, Page 1317-1323, October 2026.
Pamela F. Weiss, Hermine I. Brunner
wiley   +1 more source