Office of Business Informatics Program Description

The Office of Business Informatics (OBI) multidisciplinary staff supports the Center for
Drug Evaluation and Research (CDER) information requirements. OBI functions
include the following:

1. Managing CDER records management programs (electronic and paper )
2. Creating business reports
3. Coordinating Information Technology (IT) systems development
4. Conducting and developing training for IT systems
5. Managing and ensuring quality of FDA’s data

OBI uses the expertise of pharmacists to support these endeavors. We are in particular
need of pharmacists and pharmacy students for special projects that arise. We often deal
with drug names, routes of administration, therapeutic classes, and similar
pharmaceutical data. Our division offers students an experience where they can apply
their knowledge.

The data managed by OBI eventually gets incorporated into the Orange Book, the
Inactive Ingredient Database (IID), the Adverse Events Reporting System (AERS) and
other FDA programs. You can find information on these programs at FDA's homepage,
www.fda.gov. Working in OBI will provide an understanding of how applications—
New Drug Applications (NDA), Investigational New Drug Applications (IND)
Abbreviated New Drug Applications (ANDA), and Master Files (MF)—are processed by
the FDA.