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Part 11 guidance withdrawn

This article was originally published in The Tan Sheet

Executive Summary

FDA guidance on submission of electronic records withdrawn Feb. 3, as it "may no longer represent FDA's approach under the [current good manufacturing practice] initiative." Agency "wishes to limit the time spent by industry" reviewing the guidance, which was published in recent Federal Register (1"The Tan Sheet" Nov. 11, 2002, In Brief). FDA "may decide to reissue the draft guidance once it has reviewed it under the cGMP initiative"...

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