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In Brief: FDA "Hammer" awards

This article was originally published in The Gray Sheet

Executive Summary

FDA "Hammer" awards: FDA's Southwest Region receives Vice President Al Gore's "Hammer Award" for conducting grassroots meetings in 1995 that led to the agency's pilot initiative to allow pre-announced inspections and annotated 483s. The award recognizes government officials who advance the Administration's National Performance Review for reforming the federal government. FDA recently has received "Hammer" awards for a number of other initiatives, including: the FDA device center's Television Design and Development Branch's production, in conjunction with the Food and Drug Law Institute, of video teleconferences intended to educate industry on FDA regulations; the Office of Regulatory Affairs' Compliance Achievement Reporting System (CARS), aimed at evaluating investigator performance based on the level of industry compliance as well as on formal regulatory action ("The Gray Sheet" Sept. 23, I&W-15); mammography training workshops; and speedy approval of a protease inhibitor for the treatment of AIDS...

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