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  1. Center for Drug Evaluation and Research | CDER

Office of Study Integrity and Surveillance

Our Mission

To ensure data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (GLP) studies submitted to FDA.

Office Overview

OSIS staff support FDA's mission to protect the public health by:

  • Conducting comprehensive study-directed and surveillance inspections of firms that conduct pharmacokinetic, bioavailability/bioequivalence (BA/BE), Good Laboratory Practice (GLP), and Animal Rule (AR) studies in support of human drug applications.
  • Developing and refining strategies to improve inspection planning, execution, evaluation, and provide recommendations to CDER review divisions, while focusing on human subject safety and data integrity.
  • Conducting outreach through participation in national and international conferences and workshops, and collaborating with international regulatory agencies by conducting joint inspections, observed inspections, and shared training.

Office Leadership

Immediate Office
Office Director: Sean Kassim, PhD
Deputy Office Director: Brian Folian, J.D., M.S.

Division of New Drug Study Integrity
Division Director: Chuck Bonapace, PharmD
Deputy Division Director: Arindam Dasgupta, PhD

Division of Generic Drug Study Integrity
Division Director: Seongeun Cho, PhD
Deputy Division Director: Kimberly Benson, PhD

OSIS Publications

Metrics Overview

For more information, please contact the Office of Study Integrity and Surveillance.

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