In this free webinar, learn how early planning can help sponsors prepare for the accelerated approval pathway. The featured speakers will discuss recent FDA changes, confirmatory trial strategy, protocol design, inspection readiness and chemistry, manufacturing and controls (CMC) planning. Attendees will also explore how coordinating clinical, regulatory and operational activities earlier can help reduce development risk and keep programs on track.

TORONTO, Aug. 20, 2026 /PRNewswire/ -- 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 [1,2]. 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.

Whether teams are considering accelerated approval for a rare disease therapy or preparing an active development program, this webinar will provide strategies to help plan with confidence and accelerate the path to patients.

Register for this webinar to learn how early planning can improve accelerated approval readiness and reduce clinical, regulatory and operational risk.

Sources:

1. U.S. Food and Drug Administration. Advancing Health Through Innovation: New Drug Therapy Approvals 2025. Center for Drug Evaluation and Research; January 2026. Accessed July 2026. https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf
2. U.S. Food and Drug Administration. Advancing Health Through Innovation: New Drug Therapy Approvals 2024. Center for Drug Evaluation and Research; January 2025. Accessed July 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 

Join experts from Premier Research, Seth DePuy, PhD, Sr. Director, Regulatory & Product Strategy; and Paulla Dennis, Executive Director, Program Strategy, Rare Disease, Pediatrics, Cell and Gene Therapy, for the live webinar on Thursday, September 17, 2026, at 11am EDT (5pm CEST / EU-Central).

For more information, or to register for this event, visit Planning for Accelerated Approval: Timing is Everything.

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