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Osteoarthritis Label Should Reflect Clinical Data For Broader Claims- PhRMA

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Executive Summary

Osteoarthritis drug labeling should reflect results of specific clinical trials instead of a predetermined pain/function claim structure so that drugs obtain the broadest possible claim, the Pharmaceutical Research & Manufacturers of America suggested in April 20 comments on FDA's draft guidance on "Clinical Development Programs for Drugs, Devices and Biological Products Intended for the Treatment of Osteoarthritis."

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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