OTC foreign marketing data "simplified" review process proposed by EAPC in comments.
This article was originally published in The Tan Sheet
Executive Summary
OTC FOREIGN MARKETING DATA "SIMPLIFIED" REVIEW PROCESS PROPOSED by the European-American Phytomedicines Coalition in Jan. 2 comments to FDA. The comments suggest a bifurcated process that would allow ingredients with foreign marketing experience to enter the U.S. market more quickly than the process outlined by the agency in its Oct. 3 advance notice of proposed rulemaking on "material time/material extent" criteria for OTC marketing ("The Tan Sheet" Oct. 7, 1996, pp. 1-3).