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To print this article, all you need is to be registered or login on Mondaq.com. Earlier this year, industry became more intimately familiar with the clinical trials reporting requirements in the U.S. when, on April 27, the  U.S. Food and Drug Administration sent a notice of noncompliance to Acceleron Pharma Inc. identifying the company s failure to submit study results from a November 2017 trial that tested the efficacy of dalantercept and axitinib, proposed treatments for renal cell carcinoma. As sponsors and principal investigators seek to learn from the Acceleron example, it is important for industry to consider reporting requirements not just in the U.S., but also for

Martinh vossUs public health serviceDrug administration modernizationUs department of healthHuman servicesNational institutes of healthEuropean free trade associationDrug administrationDrug administration pressNational library of medicine pressNational libraryPublic healthEuropean unionEuropean medicines agencyAcceleron pharma incDrug administration amendments