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What To Watch As EU Clinical Trial Compliance Changes - Food, Drugs, Healthcare, Life Sciences


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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 Voss , Us Public Health Service , Drug Administration Modernization , Us Department Of Health , Human Services , National Institutes Of Health , European Free Trade Association , Drug Administration , Drug Administration Press , National Library Of Medicine Press , National Library , Public Health , European Union , European Medicines Agency , Acceleron Pharma Inc , Drug Administration Amendments , Acceleron Pharma , Clinical Trials Regulation , Trials Information , National Institutes , Drug Administration Amendments Act , Economic Area , Clinical Trials Directive , Health Service Act , Clinical Trials , Information System ,