CDER seeks regulatory science partners for drug safety

FDA's Center for Drug Evaluation and Research is seeking partners to address its drug safety-related regulatory science needs. The agency plans to issue a new report Thursday highlighting specific regulatory science initiatives that would benefit from external partnerships. The new document builds on a 2011 report identifying CDER's primary regulatory science challenges (see BioCentury Extra, July 25, 2011).

FDA is aiming to improve access to postmarket data sources and their potential use for safety analyses, improve risk assessment and management strategies, and evaluate methods it uses to communicate drug safety information to healthcare providers and patients. The agency also seeks to improve drug quality, design, manufacturing and performance; improve risk-benefit assessments; develop predictive models; and explore clinical biomarkers, all related to drug safety. ...