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 of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More
Two years after issuing guidance on data capture from electronic health records, the FDA’s Center for Drug Evaluation and Research is calling on stakeholders to help demonstrate how the use of electronic source data can help to streamline the clinical trial process. Read More
A year after a consortium of stakeholders issued a proposed wish-list of approaches to the development of drugs for Duchenne Muscular Dystrophy, the FDA issued draft guidance giving drugmakers more leeway in how those drugs are created. Read More
The European Medicines Agency last month released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More