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International Conference on Harmonization

This article was originally published in The Tan Sheet

Executive Summary

Second draft guidance defining means for electronically submitting regulatory information to FDA published in Federal Register June 14. Guidance includes changes based on comments on first draft, which was published Nov. 28 (1"The Tan Sheet" Dec. 3, 2001, p. 2). Second draft is clearer, has complete glossary of terms, doubles maximum length of a file name to 64 characters, FDA says. Separate guidance, entitled "Q1E Evaluation of Stability Data" and published same day, should instruct on "how to use stability data...to propose a retest period for the drug substance and a shelf life for the drug product." Comments on both are due Aug. 1...

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