*DRUGS, *PHARMACEUTICAL industry, *ELECTRONIC filing systems
Abstract
The article focuses on concern of U.S. Food & Drug Administration (FDA) regarding quality and completeness of data associated with making drugs and mentions that drug companies are being forced to pay attention to data. Topics include struggle of regulators with the conversion from paper-based to electronic filing, views of Barbara Unger, a former quality manager at pharmaceutical firm Eli Lilly & Co., on the same, and guidance document from nonprofit World Health Organization.