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.
Certain drug and biologic manufacturers must notify the FDA at least six months before they believe a product may be permanently discontinued or experience an interruption in manufacturing, according to a new proposed rule announced last month. Read More
To demonstrate value in the age of personalized medicine, drugmakers must adjust their marketing campaigns around patients’ real-world experiences, a new PricewaterhouseCoopers (PwC) report says. Read More
Aegerion Pharmaceuticals CEO Marc Beer’s televised comments about the company’s heart drug Juxtapid have drawn a warning letter from the FDA for failing to mention drug risks and promoting an off-label use. Read More