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Strengthening and exploring additional uses of the FDA’s Sentinel System will be a top priority of PDUFA VI, agency officials said during a Wednesday public meeting to kick off negotiations on reauthorization of the Prescription Drug User Fee Act. Read More
The FDA and its European counterpart will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring. Read More
The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee. Read More
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
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. 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
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