How the FDA are using real-world evidence in regulatory decision-making: an interview with Nicholaas Honig, Aetion

Since the passing of the 21st Century Cures Act in 2016, more and more regulatory approvals have been made by the FDA using real-world evidence to support new indications for approved products. Here, Nicholaas Honig, Associate Regulatory Counsel, Aetion highlights some of these recent FDA approvals and provides his thoughts on the evolving role of RWE to support regulatory decision-making. Please could you introduce yourself, your organization(s) and give a brief overview of your career to date? My name is Nicholaas Honig and I am an Associate Regulatory Counsel at Aetion. In this role, I support Aetion’s regulatory-focused activities, such...