FDA Drug Safety Science ‘Evolving,’ Wireless Reporting Future Eyed: CDER

While CDER is improving its drug safety efforts by giving equal weight to pre- and postmarket analysis, the center’s safety science is still evolving and may potentially include wireless technologies to transmit point-of-care data, a new FDA report states. Future directions for improving the safety of marketed drugs may also include enhanced review methodologies to analyze meta-analyses, continued advances in pharmacogenomics, secured access to electronic healthcare records and improved toxicological methods to predict adverse events, according to a report on advances in the agency’s drug safety program, issued April 20.
Washington Drug Letter