Tag Archives: Japanese Pharmaceuticals and Medical Devices Agency

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