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Osteoarthritis trials for pain improvement claim must show no worsening in function -- FDA draft guidance.

Executive Summary

OSTEOARTHRITIS PAIN IMPROVEMENT TRIALS MUST SHOW NO WORSENING IN FUNCTION in order to support a claim, FDA said in a draft "Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis" released Feb. 12. "An agent that positively affects pain or function will be granted a claim for `improvement in pain' or `improvement in function,' respectively, provided there is no major deterioration in the other measurement and in the nonsignal joint patient global measurement," the guidance states.
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