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FDA seeks osteoporosis trial design comments

Executive Summary

FDA is seeking comments to modify 11994 draft guidance on osteoporosis clinical trial design. FDA's 2notice asks "do fracture endpoint trials need to be three years in duration, or could shorter studies provide adequate evidence of a new osteoporosis drug's effectiveness and safety?" and "is it appropriate to use placebo controls in fracture endpoint trials?" An advisory committee generally agreed that such studies could be conducted ethically among low-risk patients (3"The Pink Sheet" Sept. 30, 2002, p. 17)...

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