ANDA Approval Improvements Reveal Just How Big The Backlog Is

GPhA says FDA would have to approve 150 ANDAs a month to get through its backlog; agency says it would welcome having that many approvable applications.

FDA’s recent speed boost in approving generic drug applications is laudable but still way short of the rate industry says is necessary for all pending ANDAs to be made available for marketing.

ANDA reviewers would have to approve nearly four times as many applications per month as they are currently to reach...