The FDA is working to improve the quality of NDAs and ANDAs submitted to the agency in the wake of manufacturing incidents such as the 2007 Chinese tainted heparin scandal, while putting in place a quality management system within the agency’s centers. The race among generic-drug makers to be the first to file an application for a product has led to poor quality submissions and is one example of how an inadequate focus on quality among manufacturers has become a burden on the FDA and its reviewers, Janet Woodcock, CDER director, said at the 2010 GPhA/FDA Quality by Design Workshop.

Washington Drug Letter