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Cross-labeling comments requested

This article was originally published in The Gray Sheet

Executive Summary

FDA Office of Combination Products plans public meeting next spring or summer to gather input on cross-labeling of therapeutic products, according to OCP Director Mark Kramer. At a recent MDUFMA stakeholder meeting, the combo products chief identified cross-labeling as "a very sticky, complex regulatory issue," and said the 2005 meeting would help FDA generate feedback "with an eye toward rulemaking." OCP is considering guidance on the topic (1"The Gray Sheet" Oct. 25, 2004, p. 18). Under FDA's cross-labeling policy, items intended for use with a separate product may be required to carry dual labeling...

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