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Human tissue hearing

This article was originally published in The Gray Sheet

Executive Summary

Senate Labor and Human Resources Committee schedules hearing July 19 to follow up on issues pertaining to legislation introduced last fall by Rep. Ron Wyden (D-Ore.) and Sen. Paul Simon (D-Ill.), a member of the Labor Committee. The bill would give FDA's Center for Biologics Evaluation and Research responsibility for regulation of minimally processed human tissue ("The Gray Sheet" Nov. 29, 1993, In Brief). Outstanding issues include: whether and how user fees should be applied to the tissue products, whether FDA should be authorized to decide independently to reclassify tissue as a device, and whether the bill should be amended to encompass banking of reproductive tissues such as sperm



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