🔔 Note: Stop playback at 15:44 to complete this lesson.
Presenter
Tahseen Mirza, PhD
Associate Director for Regulatory Affairs
Office of Study Integrity and Surveillance (OSIS)
Office of Translational Sciences (OTS)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This presentation outlines the vital role of the Office of Study Integrity and Surveillance (OSIS), an integral part of the FDA’s Center for Drug Evaluation and Research (CDER). OSIS’s mission is to promote public health by ensuring the welfare of study subjects and verifying the quality, study integrity, and regulatory compliance of bioavailability/bioequivalence (BA/BE), non-clinical GLP, and animal rule studies. Its vision is to improve public health by protecting study subjects and promoting properly conducted studies. OSIS supports CDER’s mission by serving as one of the last sets of eyes for authenticating data and providing assurance that data supporting regulatory decisions are reliable. This is achieved through a four-step process: select, inspect, report, and support. OSIS selects sites for risk-based, study-directed inspections, predominantly for ANDA studies, then conducts inspections to ensure the quality and integrity of studies, guided by compliance programs. Following inspections, findings are documented in Establishment Inspection Reports (EIRs), which are reviewed and classified. Finally, OSIS provides recommendations to appropriate CDER divisions, crucial for regulatory and approval decisions, and collaborates with other offices and international agencies. OSIS plays a critical role in ensuring the reliability of data submitted to the FDA.