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This article was originally published in The Tan Sheet

Executive Summary

Coalition of Gelatin Capsule Manufacturers, consisting of Banner Pharmacaps, Warner-Lambert/Capsugel and R.P. Scherer, requests FDA issue guidance for industry on sourcing and processing of gelatin to reduce the potential risk of Bovine Spongiform Encephalopathies in an Oct. 14 letter. "Almost six months have transpired since the last meeting of the [Transmissible Spongiform Encephalopathies] Advisory Committee," and "to date, FDA has not made available to the public a guideline that incorporates the committee's recommendations," the coalition says. "While we appreciate that resources are scarce at FDA...the agency should complete the task for which it sought the TSE Advisory Committee's Advice." At its April meeting, the TSE committee made specific recommendations regarding the timing of spine removal from carcasses used in gelatin manufacture ("The Tan Sheet" April 20, pp. 21-22)
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