OTC labeling "feedback" meeting with NDMA scheduled for May 8.
This article was originally published in The Tan Sheet
Executive Summary
OTC LABELING REG COMMENT PERIOD EXTENSION UNLIKELY, FDA Office of Drug Evaluation V Director Michael Weintraub, MD, said at a May 1 Nonprescription Drug Manufacturers Association industry briefing in New York City. NDMA recently requested a 90-day extension to the June 27 deadline; the industry group said it would use the extra time to analyze data from a member survey on the proposed reg and develop model labels. Separately, the Cosmetic, Fragrance & Toiletry Association requested a 120-day extension; CTFA wants to submit comments after its September board meeting ("The Tan Sheet" April 28, p. 15). FDA's labeling proposal was published for comment in the Feb. 27 Federal Register ("The Tan Sheet" March 3, pp. 3-9).
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