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FDA Focuses ANDA Reviews on Basis of Risk

This article was originally published in The Gold Sheet

Executive Summary

A risk-ranking pilot went so well that FDA’s Office of Generic Drugs has swiftly expanded use of the technique to help focus the attention of reviewers, swamped by GDUFA deadline-studded, QbD-packed ANDAs, on the quality issues that will have the greatest impact on patient safety.

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