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Merck TEA request

This article was originally published in The Rose Sheet

Executive Summary

Merck KGaA U.S. affiliate EM Industries seeks 90-day extension to convert pending citizen petition for sunscreen ingredient Eusolex 6300 into "time and extent application" for priority review. In May 21 letter to FDA, Merck counsel Buchanan Ingersoll (Washington, D.C.) says company expects to file TEA but "due to the extensive lapse of time" since petition's filing in 1980, recompiling original data "and supplementing that information with data and other relevant information generated over the last 20 years has been difficult." In April, FDA notified petitioners they have 120 days from Jan. 23 publication of "material time, material extent" rule to convert petitions into TEAs (1"The Rose Sheet" May 6, 2002, In Brief). Merck says it would consider any denial of additional time, coupled with agency's April letter, to be a "final administrative action" on the petition and would "seek relief through the judicial system"...

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