Faster time to action and facilitated review are the expected benefits when regulatory agencies use computer-assisted new drug applications (CANDAs). Although no statistics are available to support these benefits, CANDAs continue to be used widely. Sponsors began to use CANDAs in-house also, and the benefits in this area were unexpected. This research of 32 pharmaceutical sponsors showed that when CANDAs were used internally, a better quality new drug application (NDA) appears to result. Use of CANDAs by sponsors in preparing an NDA did not extend the time of submission preparation; nor did it appear to speed the process.
MathieuMP. (Ed.) CANDA: A regulatory, technology, and strategy report. Waltham, MA: PAREXEL International Corporation; 1992.
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KirkSE.Relative benefits of sponsor use of computer-assisted new drug applications (CANDAs). (Unpublished doctoral dissertation). Philadelphia, PA: Temple University School of Pharmacy; 1994.
