Who We Are:
The Office of Business Informatics (OBI) supports CDER’s regulatory decision-making by identifying, implementing, and managing CDER-wide informatic systems to meet business needs.
Director: Sridhar Mantha, M.B.A., M.S., B.Tech
Deputy Director: Tessa Brown, DHSc, MPH, BSN, RN
OBI’s pool of professionals includes multidisciplinary scientific and technical professionals such as Operations Research Analysts, Health Informatics Officers, Management Analysts, Project Management Officers, Computer Scientists, Regulatory and Technical Information Specialists, Business Informatics Analysts, Business Informatics Specialists, and Program Support Specialists.
Divisions and Teams:
- Division of Business Management Services & Solutions (DBMSS)
- Division of Data Management Services & Solutions (DDMSS)
- Division of Drug Quality and Compliance Services & Solutions (DDQCSS)
- Division of Regulatory Review and Drug Safety Services & Solutions (DRRDSSS)
- Integrated Data Management Capability Team (IDMCT)
Division of Business Management Services & Solutions
Leads the modernization and operation of workflow management and business intelligence and analytics capabilities in support of the CDER Informatics Platform
Division of Data Management Services & Solutions
Interacts with applicants, sponsors, and CDER personnel to provide accurate and timely guidance on electronic submission issues; provides oversight to the CDER document room and leads CDER records management initiatives
Division of Drug Quality and Compliance Services & Solutions
Partners with the Office of Compliance (OC), Office of Generic Drugs (OGD), Office of Management (OM), Office of Regulatory Policy (ORP), the Drug Shortages Staff (DSS) in the Office of the Center Director (OCD), and Office of Pharmaceutical Quality (OPQ) to systemically assess and prioritize business informatics in support of critical drug quality and compliance business needs.
Division of Regulatory Review and Drug Safety Services & Solutions
Partners with various CDER offices, such as Office of New Drugs (OND) and Office of Surveillance and Epidemiology (OSE), and other centers to systemically assess and prioritize business informatics in support of critical regulatory review and drug safety business needs.
Integrated Data Management Capability Team
Leads the modernization and operation of data management capabilities in support of the CDER Informatics Platform