Extended TEA deadlines
This article was originally published in The Rose Sheet
Executive Summary
FDA grants 90-day extension, until Aug. 21, for submitting for priority review "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' ability 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 among petitioners notified about extension; ingredients at issue include sunscreens, antiseptics, ginger, valerian. Agency originally had directed petitions be converted to TEAs within 120 days of Jan. 23 final reg on "material time, material extent" criteria (1"The Rose Sheet" May 6, 2002, In Brief)...