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OTC labeling

This article was originally published in The Tan Sheet

Executive Summary

FDA believes number of hours per response and total hours required for companies to implement changes required by final reg may be less than originally expected, according to Sept. 27 Federal Register notice. Agency says respondents have made several inquiries since March 1999 final rule, which "have been less than 2.5 or 4 hours per response, generally averaging 0.25 to 0.5 hour per inquiry." Feb. 22 draft guidance offering labeling mock-ups for ANDA holders also should reduce response time, FDA adds. Agency cautions it is "not currently able to estimate how much the time has been reduced" and solicits comments on the issue for up to 60 days after the FR announcement
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