Computers in the new drug application process.

J F Studebaker

doi:10.1021/ci00011a013

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Computers in the new drug application process.

J F Studebaker

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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.

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Computer Graphics Computers Databases, Factual Drug Approval Molecular Structure Software Design United States United States Food and Drug Administration Journal Article

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J F Studebaker. Computers in the new drug application process.. https://doi.org/10.1021/ci00011a013

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