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Laxative record open

This article was originally published in The Tan Sheet

Executive Summary

FDA is reopening the administrative record for OTC laxative products until Jan. 20, 2004, agency announces in Oct. 22 1Federal Register. Agency explains it "has received new data and information submitted to the rulemaking for OTC laxative drug products after the administrative record closed on the various dates" since the 1985 tentative final monograph. Separately, comments on the agency's proposal to reclassify granular psyllium as Category II (not generally recognized as safe and effective) from Category I (generally recognized as safe and effective) are due Nov. 3, FDA says (2"The Tan Sheet" Aug. 11, 2003, p. 10)...
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