A business-to-regulator system using XML: The FDA case

Kip Canfield
IFSM Department, UMBC

2:00pm Friday February 25, 2000
Lecture Hall III, Administration Building

This case describes and discusses the lessons learned from a project that computerized the application process for the Office of Generic Drugs (OGD) at the FDA. The FDA drug application process begins when sponsor pharmaceutical companies (drug developers and manufacturers) request approval of a drug product from the FDA and ends in approval or disapproval of the drug product. The project began in 1991 and began using a proprietary markup lanaguge, but ended using XML. After the description of the project, the lessons learned will be discussed using the following categories: Standards, Politics/Management, and Infrastructure. This case study offers a close look at a complex information system project that involves the federal government and a large number of private pharmaceutical firms of various types.