FDA Proposes Question-Based Review System for Generics
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FDA Proposes Question-Based-Review System for Generics
TheUS Food and DrugAdministration's Office of Generic Drugs (Rockville, MD) isdeveloping a question-based review system for its chemistry,manufacturing, andcontrols (CMC) evaluation of abbreviated new drug applications.According to the agency's Aug. 31 white paper, "Question-Based Review(QbR) for Generic Drugs: An Enhanced Pharmaceutical Quality AssessmentSystem," the new approach will focus on critical pharmaceutical qualityattributes and is a practical implementation of the principles outlinedin the agency's "CGMPs for the Twenty-First Century" and processanalytical technology initiatives. The new system, the agency says,will close the gap between the "desired state" for pharmaceuticalquality and the agency's existing CMC review practice.
