ANDA Backlog: FDA Climbs The Mountain, Will Need To Climb It Again

Agency has acted on 84% of generic applications pending when user fee program launched, but most actions were 'complete response' letters, which do not reduce review workload.

FDA has nearly scaled the mountain of ANDAs in the generic drug user fee program backlog, but could wind up climbing the mountain a second time because most may require another review.

At the end of 2015, the agency's Office of Generic Drugs completed what are known as first actions on 84%...

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