CDER Takes Action on More Than 90 Percent of GDUFA Backlog

July 15, 2016

The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced.

Woodcock said the office has taken at least first action on 2,611 ANDAs in the backlog (91.1 percent), and 1,710 PASs (90.7 percent). That is well ahead of a September 2017 deadline established under GDUFA to address 90 percent of all applications in a multi-year backlog.

The backlog in October 2012 contained more than 4,700 applications, which the agency managed to pare down to around 3,500 in January. By May, the agency had worked its way through an estimated 84 percent of the ANDAs and 88 percent of the PASs.

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