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NDMA OTC labeling "feedback" request

This article was originally published in The Tan Sheet

Executive Summary

Denied, FDA tells the trade association in a June 10 letter. "We are aware of your concerns and previously met on May 8, 1997, June 27, 1997, July 14, 1997 (NDAC meeting), and Sept. 30, 1997 to discuss NDMA's concerns and views on various OTC labeling issues. In addition, we extended the comment period for the proposed rule until Oct. 6, 1997, to allow NDMA and others additional time to adequately address the proposed rule," FDA says. "We do not need further clarification of your views and, thus, we do not consider another meeting necessary at this time." NDMA had wanted to discuss modifying the proposed labeling format and a package size exemption further. FDA published the proposed rule Feb. 27, 1997 ("The Tan Sheet" March 3, 1997, pp. 1-9). FDA also denies the same request from CTFA...
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