OTC drug labels
This article was originally published in The Tan Sheet
Executive Summary
FDA adds agenda topic to a Sept. 8-9 meeting of an advisory subcommittee comprised of members of the Nonprescription Drugs Advisory Committee and Arthritis Advisory Committee. According to an Aug. 16 Federal Register notice, the joint subcommittee will discuss proposed changes in the labeling format for all OTC drug products. The subcommittee is expected to allocate approximately one hour for discussion of the issue on the afternoon of Sept. 9. The subcommittee's main topic of discussion will be OTC analgesic efficacy data requirements and labeling indications ("The Tan Sheet" Aug. 1, p. 14)