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.
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
A new interactive clinical data platform for Apple devices is capable of not only boosting participation in data-driven disease studies, but also collecting clinical data more easily, the tech giant says. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More