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OTC labeling rule clarification on use of secondary panels requested by Apothecon.

This article was originally published in The Tan Sheet

Executive Summary

OTC LABEL RULE ATTENTION TO USE OF ALL SECONDARY PANELS requested by Princeton, N.J.-based Apothecon, a division of Bristol-Myers Squibb, in June 13 comments on FDA's proposed OTC labeling revisions. Apothecon requests that the agency clarify its policy regarding "the use of all secondary panels, rather than just one panel," for the label information that would be required under the Feb. 27 proposed rule ("The Tan Sheet" March 3, pp. 1-9). Although it does not specifically prohibit splitting the required information, FDA's proposal neither details when it is appropriate to divide the information over more than one panel nor how it should be done.
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