Abstract
November 15, 2016 — The EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline was open for public consultation until 28 February 2017.
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References
- Sergio Bonini, and Guido Rasi. First-in-Human Clinical Trials – What We Can Learn from Tragic Failures, N Engl J Med 2016; 375:1788-1789.
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