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OTC labeling rule

This article was originally published in The Tan Sheet

Executive Summary

Hours per response and total hours spent responding to "Drug Facts" labeling requirements "may be less than the numbers stated" in March 1999 OTC labeling final reg, agency says in Feb. 26 Federal Register notice. Although final rule estimated 2.5 to 4 hours per response per product, agency notes "respondents have made a number of inquiries since the final rule" was issued, with inquiries generally averaging .25 to .5 hours each. In addition, February 2001 draft guidance that provided ANDA labeling examples "should have reduced some of the hours per response and total hours for some NDA and ANDA holders," agency notes. Nevertheless, FDA says it is not "currently able to estimate how much the time has been reduced"...
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