About FDA

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: Sally Choe, PhD

Division of New Drug Bioequivalence Evaluation
Division Director: Chuck Bonapace, PharmD
Deputy Division Director: Arindam Dasgupta, PhD

Division of Generic Drug Bioequivalence Evaluation
Division Director: Seongeun Cho, PhD
Deputy Division Director: Sam Haidar, PhD

OSIS Publications

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance,
Welink, Jan, et al. "2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1-small molecules by LCMS)." Bioanalysis 7.22 (2015): 2913-2925.

Ackermann B et al., 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies). Bioanalysis. 2015 Dec;7(23):3019-34. doi: 10.4155/bio.15.214. Epub 2015 Dec 2.

Amaravadi, Lakshmi, et al. "2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3-LBA, biomarkers and immunogenicity)." Bioanalysis 7.24 (2015): 3107-3124.

Vaithianathan, Soundarya, et al. "Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir." Journal of pharmaceutical sciences (2015).

Metrics Overview
OSI Metrics Overview

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

Page Last Updated: 03/30/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English