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Revised GMP regs

This article was originally published in The Gray Sheet

Executive Summary

Proposal to modify device good manufacturing practices regulations may appear in the Federal Register by year end, according to Fred Hooten, acting director of the device center's Office of Compliance Division of Enforcement III. Speaking at the annual meeting of the Regulatory Affairs Professionals Society Oct. 5 in Washington, D.C., Hooten said the reg "is now number three on the regulation priority list"; the first are regs for the Mammography Quality Standards Act and second are contact lens reclassification rules.
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