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Dispute resolution

This article was originally published in The Tan Sheet

Executive Summary

FDA announces availability of final guidance, "Formal Dispute Resolution: Appeals Above the Division Level," in the Federal Register March 7. The guidance provides procedures that will be adopted by the Center for Drug Evaluation & Research for resolving scientific and procedural disputes that cannot be settled at the division level. The document, describing methods for formally appealing such disputes to the office or center level, bears few changes from a draft version published in March (1"The Tan Sheet" March 22, 1999, p. 18)

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