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.
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 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 to OSIS Publications and Presentations
- 2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). Kaur S, et al. Bioanalysis. 2022. PMID: 35578993
- 2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos). Neubert H, et al. Bioanalysis. 2021. PMID: 33470871
- 2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine). Spitz S, et al. Bioanalysis. 2021. PMID: 33511867
- 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity). Booth B, et al. Bioanalysis. 2019. PMID: 31833782
- Regulatory efforts in response to a decade of scientific advancement in bioanalytical methods. Haidar SH. Bioanalysis. 2019. PMID: 30945931
CDER BIMO Metrics Overview
- OSI Metrics Overview
- About OSIS Slides
- OSIS Remote Regulatory Assessment (RRA) Introduction Slides
- CDER SBIA OSIS Workshop 2022
For more information, please contact the Office of Study Integrity and Surveillance.