TITLE:

EMA: Revising the guideline on first-in-human clinical trials

BRIEF:

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.