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Study B 30-day comment period suggested by NDMA.

This article was originally published in The Tan Sheet

Executive Summary

"MEDICATION FACTS" HEADING DISCOURAGED BY NDMA in Feb. 13 comments to FDA on the agency's OTC Label Format Preference, "Study B." Noting that the "Medication Facts" heading was not mentioned in the agency's proposed rule on OTC label reform and the Study B data were presented in a manner difficult to analyze, the Nonprescription Drug Manufacturers Association recommends "FDA either re-propose this aspect of the labeling proposal or, preferably in the alternative, be silent about the use of `Medication Facts' in the final rule and make no further proposals on this matter."

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