title: Computers in the new drug application process.
abstract: Before a company can introduce a new pharmaceutical in the United States, it must receive approval of a New Drug Application (NDA) from the Food and Drug Administration. As a document that may consist of over 100,000 pages, the NDA presents the company's evidence that the new pharmaceutical is safe and effective for treating a particular medical condition. This paper describes four major issues in the NDA process: the role of computers in the FDA review, standards for compound documents and data, substitution of computer-assisted new drug applications (CANDAs) and electronic versions of other documents for paper versions, and management of the heterogeneous collection of material on which an NDA is based.
authors.affiliation: IBM Pharmaceutical Industry Center, West Orange, New Jersey 07052.
authors.forename: J F
authors.initials: JF
authors.lastname: Studebaker
mesh_terms: D003196:Computer Graphics; D003201:Computers; D016208:Databases, Factual; D017277:Drug Approval / Q000706:statistics & numerical data*; D015394:Molecular Structure; D012985:Software Design; D014481:United States; D014486:United States Food and Drug Administration