Woodcock: FDA Will Resolve Generic Backlog By End OF GDUFA I

FDA drug center chief Janet Woodcock told the Senate health committee Thursday (Jan. 28) that the agency will “absolutely” have the generic drug application application backlog cleared out when the current Generic Drug User Fee Amendments (GDUFA) expire at the end of September 2017. Some senators on the panel questioned whether the backlog and more than 40-month median approval time are contributing to rising drug prices and whether FDA could speed up approvals for generics of innovator products that have...