CDER organizational changes
This article was originally published in The Tan Sheet
Executive Summary
Office of Review Management renamed Office of New Drugs, effective Jan. 13. As of Jan. 1, newly created Office of Pharmacoepidemiology & Statistical Science (OPaSS) will include Office of Biostatistics and Office of Drug Safety (formerly Office of Post-Marketing & Drug Risk Assessment). ODS now houses MedWatch program, medication guides function. OPaSS is headed by Paul Seligman, MD (1"The Tan Sheet" Nov. 12, 2001, p. 16)...