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FDA urges sponsors and CROs to strengthen QA/QC after ANDA data-integrity findings
Summary
The presenter urged sponsors and CROs to implement robust quality-management systems, written SOPs, and ensure site access for monitoring and inspection to prevent data anomalies that can change bioequivalence outcomes or trigger enforcement actions.
The Agency official told attendees that responsibility for data integrity is shared: investigators must allow monitoring, auditing, and regulatory inspection, while sponsors must implement quality assurance and control systems and written standard operating procedures. "They need to ensure bioavailability and bioequivalence study complying with protocol and the regression," the presenter said, urging continuous process updates.
The presenter emphasized that failures in QA/QC can lead to untitled letters, required repeat studies, BX reclassifications, and overall increased review burden for FDA. He recommended multidisciplinary collaboration among review divisions, BiStats, and OSIS to detect systemic concerns early.
