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In Brief: OTC labeling regs

This article was originally published in The Rose Sheet

Executive Summary

OTC labeling regs: Awaiting final sign-off at the Office of Management & Budget and may be published in the Federal Register by the end of the year, FDA OTC Division General Counsel Gerald Rachanow said Dec. 12 at an International Business Communications conference on OTC drug marketing. The regulation will propose a standardized format and content requirements for OTC drug labeling. FDA's recently published regulatory agenda also slates release of the proposal for December. A 90-day comment period will follow...



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