XML In The Pharmaceutical Industry: Structured Product Labeling
http://www.idealliance.org/proceedings/xml04/abstracts/paper138.html

Thomas, Keith
IDEAlliance
2004

Abstract:

Pharmaceutical and biotechnology companies are required by law to compile and maintain over a multi-year life-cycle, large and complex collections of documents for submission to national regulatory agencies in order to obtain and sustain marketing approval for drugs and biologically active substances. The content includes both data and textual narrative, and is of great value in terms of intellectual property and legal liability. Over the past few years a cooperative effort between the regulators and industry has developed XML-based standards for electronic submission.