OTC label reg comment period extension requests likely to be denied -- FDA's Weintraub.
This article was originally published in The Rose Sheet
Executive Summary
COSMETIC DRUG OTC LABELING REG EXEMPTION POSSIBLE, FDA Office of Drug Evaluation V Director Michael Weintraub, MD, suggested at a May 1 Nonprescription Drug Manufacturers Association industry briefing in New York City. Weintraub said FDA is "going to consider" writing a blanket exemption for cosmetic drugs into its final rule on OTC labeling. The Cosmetic, Toiletry and Fragrance Association has submitted a formal request to the agency that special labeling regs be developed for these products ("The Rose Sheet" Oct. 9, 1995, p. 5).