FDA OFFICE OF POST-MARKETING DRUG RISK ASSESSMENT WILL TRACK PHASE IV SAFETY STUDIES; TWO DRUG RISK DIVISIONS WILL DIVIDE NME WORKLOAD, TRACK DRUGS IN TEAMS

FDA will track Phase IV safety studies through a new Office of Post-marketing Drug Risk Assessment, Center for Drug Evaluation & Research Deputy Director for Review Management Murray Lumpkin said in a memo to FDA employees Dec. 23.