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FDA asks for comment on process of implementing label reform regs.

This article was originally published in The Rose Sheet

Executive Summary

FDA SEEKS COMMENTS ON PROCESS FOR IMPLEMENTING LABEL REFORM REGS in a Sept. 14 correction to the Aug. 16 Federal Register notice announcing the upcoming public hearing on drug labeling scheduled for Sept. 29. Calling revision of the labeling sections of the monographs a "major undertaking," the agency announced that it is seeking comments on "the process that should be followed by FDA to ensure that the revisions are completed in an efficient and expedient manner." The request for public comment was "inadvertently omitted" from the Aug. 16 notice.



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