Welcome to our first Fortrea regulatory newsletter – bringing you a round-up on the latest regulatory guidance, and most importantly what it means for you and your products. Recent FDA initiatives and evolving EMA frameworks suggest a move toward earlier visibility, stronger justification and more deliberate planning across the development lifecycle. This month, we examine what these signals mean in practice—and where sponsors may need to adapt.

Stay in the loop.

Alicia Baker
McDowell
Vice President and Head of
Global Regulatory Strategy

Real-time trials: a signal of where development is heading

The FDA’s Real-Time Clinical Trials (RTCT) initiative reflects a broader shift toward
continuous engagement and earlier insight into trial progress. Rather than relying
on traditional milestone checkpoints, regulators are increasingly exploring how
real-time data could support ongoing evaluation.

Pediatric oncology: evolving expectations for PIPs

FDA and EMA expectations for Pediatric Investigation Plans (PIPs) in oncology continue to evolve, particularly around timing, data requirements and alignment with adult programmes.

Why this matters: Concentrating approval on a single study increases design, endpoint and evidence risk, making early strategic planning critical to avoid delays or regulatory challenges.

Single pivotal trials: flexibility with greater responsibility

The FDA has clarified that a single adequate and well-controlled pivotal trial may support approval, reflecting evolving approaches to trial design and development efficiency. However, the requirement for substantial evidence remains unchanged—and expectations for trial robustness may be higher.

Why this matters: Evidence planning is becoming more access-led. Sponsors may
need to prioritize comparators, accept where uncertainty cannot be eliminated, and align cross-functional teams earlier to shape an evidence strategy that supports both JCA requirements and national market access decisions.

Joint Clinical Assessments: early signals for evidence strategy

The first EU Joint Clinical Assessment (JCA) highlights how evidence expectations are translating into real-world challenges. In the initial assessment, limited comparative data meant that most PICOs could not be fully evaluated—illustrating the gap between expectations and what may be feasible in practice.

Why this matters: Evidence planning needs to become more access-led, with sponsors shaping integrated evidence strategies that support JCA requirements and national market access decisions. This means identifying evidence needs early, focusing effort where it can most influence access, and planning how to manage remaining risk.

Preparing for a regulatory inflection point?

Regulatory strategy is becoming more integrated with trial design, data planning and global alignment. Discuss your development approach with Fortrea’s regulatory team.