FDA OTC Label Comprehension/Compliance Study Urged By NDAC Members
This article was originally published in The Tan Sheet
Executive Summary
FDA should conduct "some general studies that aren't specific to products or symptoms that help us deter-mine a consumer's general ability to self diagnose" based on what they read in the label, Nonprescription Drugs Advisory Committee Consumer Representative Kathleen Hamilton suggested July 20. Her remarks came during the committee's review, with the Arthritis Advisory Committee, of Merck's Rx-to-OTC switch proposal for the muscle relaxant, Flexeril (cyclobenzaprine 5 mg) (1see related stories, pp. 3-8).