Planning for Accelerated Approval: Timing is Everything

Accounting for nearly one-quarter of novel drug approvals in 2025 compared to just 14% in 2024, accelerated approvals are rebounding as the industry adapts to recent FDA updates that reshaped the pathway. While accelerated approval remains a valuable option for therapies addressing serious conditions and unmet medical needs, expectations have changed.

Today’s sponsors must demonstrate not only compelling early clinical evidence, but also develop a well-defined strategy for confirmatory trials, regulatory compliance and commercialization well before submitting for approval.

In this webinar, discover why timing is one of the most critical factors for accelerated approval. The featured speakers will discuss how early planning across clinical development, protocol design, confirmatory trial strategy, inspection readiness and CMC can reduce risk and keep development programs on track. Attendees will gain insights into aligning cross-functional teams, anticipating potential challenges and building a development strategy designed to support long-term success.

Speakers: Seth DePuy, PhD & Paulla Dennis (Premier Research)