In Brief: OTC labeling studies

OTC labeling studies: Office of Management & Budget approves FDA label comprehension and preference studies involving 2,100 subjects July 17. The approval allots a timeframe ending Nov. 30 for the research project. However, FDA may have administrative procedures available to obtain additional time. The Nonprescription Drug Manufacturers Association expressed concerns with the studies in a June 13 letter to OMB ("The Tan Sheet" June 23, p. 5). Separately, FDA announced Aug. 1 it is extending the comment period on two additional OTC labeling studies from July 22 to Sept. 30. The studies will assess consumer comprehension of product statements of identity and analgesic alcohol warnings ("The Tan Sheet" June 2, p. 8)...