Europe Tackles New Rules for Non-Clinical to Clinical Handoff.

The article looks at the proposed revisions by the European Medicines Agency (EMA) to guidance on first-in-human clinical trials. Topics covered include the EMA being prompted to revisit the guidance following the death or hospitalization of volunteer subjects during a trial performed by French research organization Biotrial for drugmaker Bial, the suggestion by the EMA to explore a dozen of areas when dealing with protocols, and the need to expand the non-clinical aspects of the guideline.