FDA claims success in speeding up approvals

WASHINGTON - The FDA is declaring success in its implementation of the Prescription Drug User Fee Act of 1992 (PDUFA), reporting that the user fee program has reduced the backlog of NDAs and speeded the approval process.

In its Second Annual Performance Report on PDUFA, the agency says that Congress instructed it "to clear an overdue backlog equivalent to more than six months of normal receipts while, at the same time, readying our process to accelerate the review of new submissions."...