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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Foreign ingredient petitions
FDA will "give priority" to reviews of time and extent applications (TEAs) submitted by firms that previously petitioned to include foreign-marketed ingredients in OTC monographs, agency reiterates in letters to ingredient suppliers, their attorneys. As outlined in Jan. 23 final reg, petitions must be converted to TEAs "within 120 days" of rule's publication (1"The Tan Sheet" Jan. 28, 2002, p. 3). Letters to Ciba Specialty Chemicals, EM Industries, BASF counsel, Haarmann & Reimer counsel, dated from April 19 to April 25, advise firms that FDA will not take "further action" on their respective petitions for sunscreen ingredients. Similar letters also sent to P&G (antiseptics), European-American Phytomedicines Coalition (valerian/sleep aid, ginger/antiemetic petitions) and American Vitamin Products (ginger)...
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