To mitigate regulatory risks, stakeholders can adopt several strategies, including: - Early Engagement with Regulatory Bodies: Engaging with regulatory agencies early in the development process can help identify potential issues and streamline the approval process. - Robust Clinical Trial Design: Designing clinical trials that meet regulatory requirements from the outset can reduce the risk of delays and ensure a smoother approval process. - Adaptive Regulatory Pathways: Utilizing adaptive regulatory pathways, such as the FDA's Breakthrough Therapy designation or the EMA's PRIME scheme, can expedite the development and approval of promising cancer treatments.
