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Laxatives monograph clarification

This article was originally published in The Tan Sheet

Executive Summary

CHPA asks FDA to accept the statement of identity "fiber laxative" as well as "the indication 'Fiber therapy for relief of occasional constipation' [which may be followed by '(irregularity)']" in a Jan. 20 letter. The trade group also requests clarification on whether "'fiber laxative' may be used as an alternative to 'bulk-forming laxative.'" CHPA's request comes after the October 2003 reopening of the administrative record for OTC laxatives (1"The Tan Sheet" Oct. 27, 2003, In Brief)...

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