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.
As the coming year approaches, EU regulators and pharma are ratcheting up their arguments for and against a plan to make more patient-level clinical trial data publicly available, beginning Jan. 1. Read More
If EU regulators and pharma cannot agree on how to handle publication of clinical trial data, drugmakers may delay filing applications in Europe to preserve exclusivity, a Pfizer official says. Read More