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 FDA has again shot down Mylan and Biocon’s copycat of Sanofi’s Lantus (insulin glargine) with a complete response letter, pending the completion of corrective actions at Biocon’s Malaysian insulin plant. Read More
A study by the FDA and EMA comparing their decisions on drug marketing applications found the two agencies align in most cases — but sometimes reach different conclusions about a drug’s efficacy. Read More
The FDA on Thursday approved Genentech’s Rozlytrek (entrectinib) for adults and adolescents who have cancers with a common biomarker — only the third time the agency has approved a cancer treatment on the basis of a biomarker rather than for treatment of a specific tumor. Read More