FDA considering new drug quality office

FDA is considering the creation of a new office to oversee quality throughout the lifecycle of a drug, according to a memo from Janet Woodcock, director of the agency's Center for Drug Evaluation and Research. The new Office of Pharmaceutical Quality would take on some of the functions currently within the Office of Pharmaceutical Science, as well as some functions from the Office of Manufacturing and Product Quality in the Office of Compliance. Woodcock said it is imperative that CDER "have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety." ...