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FDAnews Drug Daily Bulletin
July 5, 2012 | Vol. 9 No. 131
EMA to Revise Multiplicity Points-to-Consider Guideline
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is seeking public input as it works to update its points-to-consider document on multiplicity issues in clinical trials. The revised document will reflect new methods and concepts for addressing multiplicity in trials that have emerged since the points-to-consider paper was first issued in 2002. It should result in an improved standard of regulatory assessment of confirmatory trials and improve sponsors’ trial planning, the May 24 concept paper states.
Clinical Trials Advisor
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