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.

For the complete white paper

–Laura Bush