CTFA OTC labeling "feedback" request
This article was originally published in The Rose 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 and Sept. 30, 1997 to hear industry's concerns about small package and drug-cosmetic labeling issues. In addition, we extended the comment period for the proposed rule until Oct. 6, 1997 to allow CTFA 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." CTFA had wanted to discuss the proposed reg's application to cosmetic drugs, particularly those products not subject to dosage limitations, the cost of relabeling and the need for a small package exemption. FDA published the proposed rule Feb. 27, 1997 ("The Rose Sheet" March 3, 1997 pp. 11-13). FDA also denied the same request from NDMA...
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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 and Sept. 30, 1997 to hear industry's concerns about small package and drug-cosmetic labeling issues. In addition, we extended the comment period for the proposed rule until Oct. 6, 1997 to allow CTFA 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." CTFA had wanted to discuss the proposed reg's application to cosmetic drugs, particularly those products not subject to dosage limitations, the cost of relabeling and the need for a small package exemption. FDA published the proposed rule Feb. 27, 1997 ("The Rose Sheet" March 3, 1997 pp. 11-13). FDA also denied the same request from NDMA.... |