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BSE/TSE

This article was originally published in The Tan Sheet

Executive Summary

HHS meeting for industry input on how department's BSE/TSE Action Plan "can capitalize on the human and physical resources of the pharmaceutical and biotechnology industries" will be held Sept. 24, 9 a.m. at the Hubert Humphrey Building, 200 Independence Ave., SW, Washington, D.C. Plan, which was unveiled Aug. 23, notes FDA will expand policies to prevent potential exposure to TSE through drugs, foods, dietary supplements by using pre-approval reviews and "targeted post-marketing review of specific entities that may either contain at-risk bovine material" or may be exposed to at-risk materials during manufacture. Action plan says FDA will "pursue studies to evaluate the safety and effectiveness of sterilization/decontamination/inactivation procedures" that can become part of GMPs
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