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FDA presenter outlines data-integrity standards for ANDA reviews
Summary
An FDA presenter reviewed core data-integrity principles for abbreviated new drug applications, explaining LCOVA principles, inspection classifications, and why data accuracy matters for patient access to generics.
An Agency official, a presenter from the Office of Bioequivalence at the Food and Drug Administration, opened the session by defining data integrity as central to regulatory review and public-health protection. "Data integrity refers to accuracy, completeness, and the reliability of the data throughout its life," the presenter said, and framed these principles as foundational to ANDA evaluation.
The presenter listed FDA's LCOVA principles—Attributability, Legibility, Contemporaneousity, Original record, and Accuracy—and explained inspection outcomes used by FDA (No Action Indicated, Voluntary Action Indicated, Official Action Indicated). The presentation stressed that weak data integrity can delay patient access to generic drugs, prompt untitled letters to CROs, and impose financial and reputational costs on applicants.
