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.
The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More
The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More
The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the European Commission, the agency said in an action plan. Read More