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This article was originally published in The Tan Sheet

Executive Summary

OTC "NATURALISTIC" STUDIES TO BE DISCUSSED by Tufts University Center for the Study of Drug Development Director Louis Lasagna, MD, at a Sept. 8-9 meeting of a subcommittee comprised of FDA's Nonprescription Drugs Advisory Committee and Arthritis Advisory Committee. "Naturalistic" studies, also known as "actual-use" trials, evaluate whether labeling information is effectively communicated to consumers, what adverse events may arise, and generally how the product performs under actual conditions of use.





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