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Perrigo

This article was originally published in The Tan Sheet

Executive Summary

Burden of providing drug listing information "could be greatly reduced if FDA were to eliminate the requirement to send a representative label and/or carton" with listing forms, OTC private labeler tells agency in Dec. 13 comments. Perrigo instead suggests representative labeling could be supplied to FDA upon request. Firm estimates its time "required to prepare a drug listing submission without representative labeling would be reduced by 75% (240 hours)." Moreover, change would reduce FDA processing time and "facilitate the feasibility of electronic submissions," Perrigo maintains
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