In the News

Alistair Davidson, Patricia Hurley and John Watkins discuss the growth of international products and the ensuing need for regulatory harmonization.

Stephen Peroutka talks about the challenges related to assessing and evaluating depression.

David Hillman and Clare Ryder outline the pharmacovigilance activities that a prospective marketing authorization holder will need to accomplish in advance of and throughout the application process.

Pat Mann, Kirsten Messmer and Luis Arthur Pelloso provide an overview of new FDA guidances related to oncology drug development.

Rob Petrie comments on some of the keys to the successful use of wearables in clinical trials.

Kirsten Messmer and Charity-Anne Schuller discuss how to maximize regulatory intelligence and offer best practices recommendations.

John Watkins discusses investigational medicinal product dossier requirements for US sponsors planning to submit clinical trial applications in EU member states.

Steven Zdravkovic examines options for extractable and leachable studies to evaluate leaching from primary packaging into lyophilized drugs.

Niklas Morton explains how the new collaboration will help pharma companies create better optimized protocols that will prove to be more attractive to sites and investigators because they are tailored to their patient population.