FDA Meets ANDA Backlog Goal Early, Still Doesn't Feel Out Of Woods

Office of Generic Drugs reviewed more than 90% of official GDUFA backlog of pending applications, but many still will require more work.

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FDA is celebrating a major review milestone for generic drugs, but the reality remains that much of that weight has yet to come off the agency's shoulders.

A memo from Center for Drug Evaluation and Research Director Janet Woodcock released July 11 trumpeted the achievement: as of July 1 FDA had reviewed more than 90% of the official generic drug user fee

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