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Aseptic processing concept paper

Executive Summary

FDA expects to release a "concept paper" on aseptic processing in time for the Pharmaceutical Science Advisory Committee to review it at a meeting tentatively scheduled for Oct. 21-22. Industry has called upon FDA to revise its guidance on aseptic processing (1"The Pink Sheet" April 22, p. 18). FDA's aseptic processing guidance was issued in 1987; the agency is preparing an updated draft guidance it hopes to publish by the end of the year...
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