Executive Summary

ANDA BACKLOG WILL BE TACKLED BY FDA NEW DRUG DIVISION CHEMISTRY REVIEWERS under a plan developed by FDA last week. According to the plan, the FDA Office of Generic Drugs will select 50-60 pending original ANDAs over the next two months and distribute them to NDA chemist reviewers, who will complete reviews of the chemistry portion of the applications. The ANDAs will then be sent back to the Division of Generic Drugs for further review. Each of the chemists in the nine NDA review divisions will be assigned an ANDA, which could take from four to 15 days to review. The chemists have been asked to contribute 20 hours of overtime per pay period to the effort. NDA review chemists assigned to the Generics division in April ("The Pink Sheet" April 30, T&G-1) will return to their divisions to review ANDAs. FDA said that it will monitor what effect the plan will have on the progress of NDA reviews. The Division of Generic Drugs currently has a backlog of about 550 overdue original ANDAs, 1,100 pending original ANDAs and thousands of supplements.