What has CDER done to improve its handling of disqualification actions?
In July 2009, CDER’s Office of Compliance, Division of Scientific Investigations (DSI), realigned its organizational structure to create a branch that focuses predominantly on serious allegations of non-compliance and cases that appear to warrant disqualification. Having staff responsibilities for this area concentrated in one branch is improving the Center’s handling of the disqualification process. The realignment has reduced competing priorities and improved consistency in these matters. For example, in the past, the same DSI staff members responsible for processing disqualification matters were also responsible for overseeing clinical investigator inspections associated with New Drug Applications (NDAs), so that actions such as disqualification had to compete with review of inspections associated with NDA-related deadlines. Q: How have these changes affected the time it takes CDER to complete disqualification actions? A: The changes within CDER, specifically within DSI, have signif
