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.
To mark Africa Malaria Day earlier this week, Novartis announced it delivered 4.7 million courses of its life-saving malaria drug, Coartem, to Tanzania, where malaria is the leading cause of death in both children and adults. Read More
Roche's pending applications for investigational erythropoiesis-stimulating agent (ESA) Mircera in the U.S. and Europe are proceeding according to plan, William Burns, CEO of Roche's pharma division, said. Read More
The UK Department of Health (DoH) is urging all medicines and medical technology manufacturers to use the GS1 autoidentification and data capturing (AIDC) system for tracking products supplied to the English National Health System (NHS).
Language in newly signed free trade agreements (FTAs) covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of lawmakers contends.
Trade representatives from the U.S. and South Korea April 1 successfully concluded months-long negotiations on a fair trade agreement (FTA) that includes provisions to increase access to innovative medicines and medical technologies and lengthen patent exclusivity for original products.