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Anticaries monograph effective date delayed until April 1997 -- FDA final rule.

This article was originally published in The Tan Sheet

Executive Summary

ANTICARIES FINAL MONOGRAPH EFFECTIVE DATE EXTENDED SIX MONTHS from Oct. 6, 1996 to April 7, 1997, according to an FDA final rule recently published in the Federal Register. The delay will allow manufacturers time to revise labeling in response to a "minor revision" of the second general warning for anticaries products, FDA explained; the revision is a "technical amendment" to the final monograph for OTC anticaries drug products. The monograph was published in October 1995 ("The Tan Sheet" Oct. 16, 1995, p. 10).





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