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NDMA advocates label reform through expansion of FDA's flexibility policy.

This article was originally published in The Tan Sheet

Executive Summary

NDMA URGING LABEL REFORM THROUGH "FLEXIBILITY POLICY" EXPANSION, Senior VP-Science and Technology William Soller, PhD, declared at a Sept. 29 FDA public hearing on OTC labeling. The policy, adopted by FDA in 1986, allows the use of alternate, non-monograph wording in the Indications and Directions sections of OTC labels so long as the statements are truthful and not misleading. The policy states that "within limits, there can be various ways of accurately stating the same thing, some of which may even be more meaningful" than the monograph language.

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