The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
Drugmakers should establish a company task force of upper management and quality personnel to prevent drug shortages, according to new good practice guidelines developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
A multidistrict mass tort suit filed July 1 in Illinois accuses Bristol-Myers Squibb and Sanofi of recklessly promoting the benefits of their blockbuster blood-thinner Plavix, despite knowing it was “defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings as to dangers associated with its use.” Read More