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FDA Proposes QbR for New Drugs to Level the Playing Field for CMC Reviews

This article was originally published in The Gold Sheet

Executive Summary

FDA has proposed to expand the use of question-based review, or QbR, to new drugs as part of its efforts to harmonize new and generic drug chemistry reviews. This reflects the agency’s latest efforts to improve the quality of brand and generic drugs by levying “equal expectations” for both.

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