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CDER guidances

This article was originally published in The Tan Sheet

Executive Summary

FDA drug center plans to issue five OTC-related guidance documents in fiscal 2003 (beginning Oct. 1) covering: actual use trials; label comprehension studies; OTC drug labeling; questions and answers on labeling; and time and extent applications for inclusion of foreign-marketed ingredients in monographs. Several others, such as those covering electronic submissions and generics, also could extend to OTCs. List of 1CDER guidances is posted on agency's Web site...





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