01-Dec-2017: Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

A commentary on the revision of the first-in-human guidelines has been published in Clinical Pharmacology and Therapeutics. It is available at wiley.com (open access).

The overviews of comments received during the public consultations on the concept paper and the revised guideline on ‘Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products’ are available on the EMA website at www.ema.europa.eu.