ANDA backlog

Executive Summary

Plan to unblock ANDA review jam will be considered at a Center for Drug Evaluation and Research meeting on Sept. 17. A center plan could issue as early as the end of the week. At an FDA chemists' "retreat" in Harpers Ferry, West Virginia, on Sept. 6 and 7, CDER Director Peck charged the center's chemists with devising a plan to eliminate the backlog of ANDAs. At the conference, Peck suggested that a possible strategy might be to assign several ANDAs a month to new drug evaluation divisions, or, alternatively, send more NDA reviewers to review ANDAs in the Generics Division.