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Extended TEA deadlines

This article was originally published in The Tan Sheet

Executive Summary

FDA grants 90-day extension, until Aug. 21, for priority review submission of "time and extent" applications based on previously filed citizen petitions to include foreign-marketed ingredients in OTC monographs. Agency's June 20 letters to various firms recognize several factors limiting companies' abilities to complete applications by original May 23 deadline, including age of original petitions, foreign locations of parent companies. Merck KGaA, BASF, P&G, European-American Phytomedicines Coalition were among petitioners notified about extension; ingredients at issue include sunscreens, antiseptics, ginger, valerian (1"The Tan Sheet" May 6, 2002, In Brief)...

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