ANDA label proofreading deficiencies still holding up approvals, OGD study finds.

Executive Summary

ANDA LABELING DEFICIENCIES: ONE-THIRD DUE TO PROOFREADING PROBLEMS, according to a 1994 study recently released by FDA. The report by the Office of Generic Drugs Labeling Review Branch contends that "improved proofreading, being familiar with the full range of references in the Code of Federal Regulations, and becoming familiar with the agency preferences will significantly reduce the number of labeling deficiencies cited in `not approvable' letters and greatly facilitate the review process."