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FDA's acceptance of Latin America, Asia data for "material time/extent" criteria urged.

This article was originally published in The Rose Sheet

Executive Summary

FDA ACCEPTANCE OF LATIN AMERICA, ASIA FOREIGN USE DATA URGED by the Nonprescription Drug Manufacturers Association in Dec. 30 comments on the agency's proposed criteria defining the terms to "a material time" and for "a material extent," with regard to the approval of new OTC "conditions of use," such as active ingredients, indications and dosage forms, for nonprescription drugs reviewed within the monograph system. "It is the quality and detail of the marketing data, rather than its conformance to preconceived notions of source or culture, that should be the touchstone of acceptability," NDMA maintains in its support for foreign use data from Latin America and Asia.
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