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FDA dispute resolution

This article was originally published in The Gray Sheet

Executive Summary

June 16 direct-to-final rule implementing Sec. 404 of the FDA Modernization Act is withdrawn "because the agency received significant adverse comment." The rule, issued in compliance with the scientific dispute resolution provision of FDAMA, provided that controversies should be resolved with "established mechanisms." It also amended existing regulations to allow manufacturers of drugs and devices to request review of a scientific controversy by an advisory panel. The Health Industry Manufacturers Association had called on FDA in Aug. 31 comments to withdraw the rule because it would have failed to follow the law and been ineffective in implementing Congress' intent ("The Gray Sheet" Sept. 14, p. 9)

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