Executive Summary

FDA's latest public estimate of when it will issue a proposed rule on sunscreen UVA/UVB claims is April 2003, according to the agency's 1unified agenda, appearing in the May 13 Federal Register. The target date is beyond previous indications from the agency that amendment to sunscreen final monograph would be published before the end of 2002. Agenda targets December for release of proposal providing flexibility for labeling of small one- or two-dose "convenience" size OTC drugs. While rulemaking proceeds, such products are excused from complying with OTC drug labeling requirements (2"The Rose Sheet" April 8, 2002, p. 10). Current OTC review agenda is more abbreviated than usual; FDA decided to list only those actions expected to be completed within next 12 months, the agency said...