Tag Archives: Japanese Pharmaceuticals and Medical Devices Agency

Eckert & Ziegler’s GalliaPharm® Generator Powers Groundbreaking Cancer Diagnostic Trial in Japan

(IN BRIEF) Eckert & Ziegler, in collaboration with Novartis Pharma K.K., is expanding Ga-68 labeled diagnostics in Japan through a clinical trial approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Utilizing Eckert & Ziegler’s GalliaPharm® generator, the trial … Read the full press release

EMA and US FDA published joint first conclusions of parallel assessment of quality-by-design applications (QbD)

29-8-2013 — /EuropaWire/ — The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and … Read the full press release