Post by IQVIA

Innovative evidence strategies are essential in rare and ultra-rare diseases, where traditional trial models are often not feasible. In this new article, IQVIA’s Julien Heidt discusses how the Rare Disease Evidence Principles (RDEP) process and the FDA’s Plausible Mechanism Framework enable greater use of real-world evidence and fit-for-purpose data strategies to support regulatory decision-making. Learn more: https://bit.ly/4yr5CIa