Industry News

FDA’s Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II

Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators Thursday that FDA is making significant progress in reducing the backlog of abbreviated new drug applications (ANDAs) for generics and the agency expects that it will be fully caught up by the next re-authorization of the Generic Drug User Fee Act (GDUFA) in 2017.