Sponsored Presentation: A regulatory affairs year to remember: Leveraging learnings to move forward in 2026

2025 will undoubtedly be a regulatory year to remember, as changes at the FDA have had a profound and immediate effect on the Agency’s review and approval of drugs and devices. Executive orders, layoffs, review delays, cancellations of advisory committee meetings, and seismic shifts in scientific decision-making have all contributed to an unprecedented level of regulatory uncertainty.

Despite these uncertain times, regulatory teams have a job to do—get their product approved. And one thing that is not changing: FDA will continue to be part of the review and approval process.

In this session, we are leaving politics aside. It’s all about practicalities and the new reality of regulatory reviews and approvals in the US. We will discuss what’s happening now and explore challenges and opportunities on the horizon, exploring topics like real-world evidence and other pathways to substantial evidence of efficacy, artificial intelligence, and upcoming PDUFA negotiations.

Hear from former FDA staff, legal counsel, and journalists who will share their perspective on the changes to the review process, the impact on scientific predictability, and what it will take to make progress in uncertain times.