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OTC analgesic backgrounder

This article was originally published in The Tan Sheet

Executive Summary

FDA announces availability of background document outlining the issues to be discussed at the Sept. 8-9 meeting of a newly formed advisory subcommittee comprised of members of NDAC and FDA's Arthritis Committee to discuss appropriate OTC analgesic indications and the clinical data requirements to support those uses ("The Tan Sheet" July 19, p. 1). In a July 22 Federal Register notice, FDA explained that the background document is being made available so that "interested parties are aware of the issues that are the subject of the committee discussion." FDA also is opening a docket for comments
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