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  1. CDER Offices and Divisions

Office of Study Integrity and Surveillance

The Office of Study Integrity and Surveillance (OSIS) is within the Office of Translational Sciences (OTS).

Our Mission

To ensure data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (or Good Laboratory Practice (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, Ph.D. 
Deputy Office Director: Brian Folian, J.D., M.S.

Division of New Drug Study Integrity 
Division Director:  Arindam Dasgupta, Ph.D.

Acting Deputy Division Director: VACANT

Division of Generic Drug Study Integrity 
Division Director: Seongeun Cho, Ph.D. 
Deputy Division Director: Kimberly Benson, Ph.D.

OSIS Publications and Presentations

Zhang J, Bonapace C, Dasgupta A, Folian BJ, Kassim SY, Faustino PJ. 2025, Reanalysis of Plasma Samples Collected from a CRO Reveals Possible Patterns of Bioanalytical Misconduct, AAPS J., 27(6):158, doi: 10.1208/s12248-025-01163-1.

Mirza T, Fenty-Stewart N, Mitchell C, Folian B, Kassim S, 2025 Use of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective, AAPS PharmSciTech, 26(1):20. doi: 10.1208/s12249-024-03024-0.

Wojcik J, Sikorski T, Wang J, Huang Y, Sugimoto H, Baratta M, Ciccimaro E, Green R, Jian W, Kar S, Kim YJ, Lassman M, Mohapatra S, Qian M, Rosenbaum AI, Sarvaiya H, Tian Y, Vainshtein I, Yuan L, Tao L, Ji A, Kochansky C, Qiu H, Maes E, Chen LZ, Cooley M, Dufield D, Hyer E, Johnson J, Li W, Liu A, Lu Y, Meissen J, Palandra J, Tang X, Vigil A, Wei W, Vinter S, Xue Y, Yang L, Zheng N, Benson K, McCush F, Liang Z, Abberley L, Andisik M, Araya M, Cho SJ, Colligan L, Dasgupta A, Dudek M, Edmison A, Fischer S, Folian B, Garofolo F, Ishii-Watabe A, Ivanova D, Gijsel SK, Luo L, McGuinness M, 'Day CO, Salehzadeh-Asl R, Neto JT, Verhaeghe T, Wan K, Whale E, Yan W, Yang E, Zhang, 2025, 2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (Part 1A - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV), J. Bioanalysis, 17(5):299-337, doi: 10.1080/17576180.2025.2450194.

Javidnia M, Irier HA, Kassim S, Cho SJ, 2024, Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance, AAPS PharmSciTech, 25(7):240, doi: 10.1208/s12249-024-02967-8.

Baratta M, Jian W, Hengel S, Kaur S, Cunliffe J, Boer J, Hughes N, Kar S, Kellie J, Kim YJ, Lassman M, Mehl J, Morgan L, Palandra J, Sarvaiya H, Zeng J, Zheng N, Wang J, Yuan L, Ji A, Kochansky C, Tao L, Huang Y, Maes E, Barbero L, Contrepois K, Ferrari L, Fu Y, Johnson J, Jones B, Kansal M, Lu Y, Post N, Shen HH, Xue YY, Zhang YC, Biswas G, Cho SJ, Edmison A, Benson K, Abberley L, Azadeh M, Francis J, Garofolo F, Gupta S, Ivanova ID, Ishii-Watabe A, Karnik S, Kassim S, Kavetska O, Keller S, Kossary E, Li W, McCush F, Mendes DN, Abhari MR, Scheibner K, Sikorski T, Staack RF, Tabler E, Tang H, Wan K, Wang YM, Whale E, Yang L, Zimmer J, Bandukwala A, Du X, Kholmanskikh O, Gijsel SK, Wadhwa M, Xu J, Buoninfante A, Cludts I, Diebold S, Maxfield K, Mayer C, Pedras-Vasconcelos J, Abhari MR, Shubow S, Tanaka Y, Tounekti O, Verthelyi D, Wagner L, 2024, 2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine), Bioanalysis, 16(9):307-364, doi: 10.1080/17576180.2024.2347153.

Zhang J, Dasgupta A, Ayala R, Bonapace C, Kassim S, Faustino PJ, 2024, Internal standard variability: root cause investigation, parallelism for evaluating trackability and practical considerations, Bioanalysis, 16(15):771-776, doi: 10.1080/17576180.2024.2348939.

Yu C, Jiang W, Matta M, Wang R, Haidar S, Seo H, 2024, Lessons learned from regulatory submissions involving endogenous therapeutic analyte bioanalysis, Bioanalysis, 16(3):171-184, doi: 10.4155/bio-2023-0209.

Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, Kellie J, Li W, Mehl J, Qian M, Qiu X, Sirtori FR, Rosenbaum AI, Sikorski T, Surapaneni S, Wang J, Wilson A, Zhang J, Xue Y, Post N, Huang Y, Goykhman D, Yuan L, Fang K, Casavant E, Chen L, Fu Y, Huang M, Ji A, Johnson J, Lassman M, Li J, Saad O, Sarvaiya H, Tao L, Wang Y, Zheng N, Dasgupta A, Abhari MR, Ishii-Watabe A, Saito Y, Mendes Fernandes DN, Bower J, Burns C, Carleton K, Cho SJ, Du X, Fjording M, Garofolo F, Kar S, Kavetska O, Kossary E, Lu Y, Mayer A, Palackal N, Salha D, Thomas E, Verhaeghe T, Vinter S, Wan K, Wang YM, Williams K, Woolf E, Yang L, Yang E, Bandukwala A, Hopper S, Maher K, Xu J, Brodsky E, Cludts I, Irwin C, Joseph J, Kirshner S, Manangeeswaran M, Maxfield K, Pedras-Vasconcelos J, Solstad T, Thacker S, Tounekti O, Verthelyi D, Wadhwa M, Wagner L, Yamamoto T, Zhang L, Zhou L, 2023, 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine), Bioanalysis, 15(16):955-1016, doi: 10.4155/bio-2023-0167.

CDER BIMO Metrics Overview

Contact

For more information, please email the Office of Study Integrity and Surveillance at  CDER-OSIS@fda.hhs.gov



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