🔔 Note: Stop playback at 1:11:49 to complete this lesson.
Presenter
Monica Javidnia, PhD
Staff Fellow
Division of Generic Drug Study Integrity (DGDSI)
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 provides an overview of clinical inspections for bioavailability/bioequivalence (BA/BE) studies conducted by the FDA’s Office of Study Integrity and Surveillance (OSIS). These inspections fall under the Bioresearch Monitoring (BIMO) program, ensuring scientifically valid and reliable data while protecting human subjects. OSIS, comprising divisions like Generic Drug Study Integrity (DGDSI), collaborates closely with the Office of Regulatory Affairs (ORA) and the Collaboration Risk Evaluation and Surveillance Team (CREST). CREST selects sites for inspection across various study types, including PK, clinical, immunogenicity, and analytical BA/BE studies. The general workflow involves OSIS sending inspection assignments to ORA, who then conduct on-site inspections or Remote Regulatory Assessments (RRAs) and prepare reports of their findings. OSIS reviewers then evaluate these reports, summarize the inspection, and provide recommendations to applicable review divisions regarding study conduct, subject safety, data reliability, and regulatory compliance. ORA investigators examine a wide range of study components, including facility workflow, personnel interviews, protocol adherence, informed consent, source documentation, drug accountability, and equipment records. Common issues identified include protocol deviations and poor recordkeeping, which can impact data integrity and sample traceability. OSIS ultimately provides the final inspection classification (No Action Indicated, Voluntary Action Indicated, or Official Action Indicated), ensuring that all data supporting regulatory decisions are reliable.