FDA to discuss patient-focused drug development

FDA will hold a public meeting and a series of periodic stakeholder meetings to discuss the agency's patient-focused drug development initiative, which FDA created to fulfill performance commitments made as part of PDUFA reauthorization. The goal of the initiative is to obtain patient perspective on disease severity and currently available treatments for a set of disease areas to enhance FDA's risk-benefit assessment in regulatory decision-making (see BioCentury, July 2).

At the Oct. 25 public meeting, FDA is seeking comments on a preliminary list of about 40 potential disease areas. The agency will use feedback to select 20 disease areas for which it will hold individual public meetings over the next five years to discuss topics including the impact of the disease on patients, the measures of benefit that matter most to patients and the adequacy of existing treatment options. ...