Industry / United States
Generics Application Backlog Continues To Grow
August 2008 | Industry NewsAccording to the head of the US FDA's Office of Generic Drugs, Gary Buehler, the average time the agency took to evaluate a generic drug application was 19 months in 2007, more than two months longer than in 2006. In October 2007, the FDA launched the Generic Initiative for Value and Efficiency (GIVE) to streamline the generic drug approval process. However, Buehler expects the backlog of generic drug applications at the FDA to continue to rise. He forecasts that the backlog will exceed 1,500 before the end of 2008, around three times the 515 generic drugs that were awaiting review
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