Understand evolving FDA expectations, strengthen confirmatory trial planning, and coordinate critical development workstreams to support accelerated approval readiness.
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Session Overview
Accelerated approval can provide earlier patient access to therapies for serious conditions by allowing sponsors to rely on surrogate or intermediate clinical endpoints. But the pathway still requires sponsors to meet FDA standards for safety and efficacy and to verify clinical benefit through confirmatory trials.
Recent regulatory reforms, including FDORA, have increased the importance of planning those confirmatory trials earlier in development. Sponsors must now think beyond the initial approval milestone and build a coordinated strategy that accounts for confirmatory evidence, regulatory commitments, operational feasibility, manufacturing readiness, and commercialization.
In this on-demand webinar, our experts explore practical strategies for keeping confirmatory trials on track, managing operational challenges, and maintaining alignment with FDA expectations throughout development.
What You’ll Learn:
- How recent FDA reforms have changed expectations for accelerated approval and confirmatory trial planning
- Why confirmatory trials should be underway or credibly advanced around the time of approval
- How to align clinical, protocol, operational, quality, and CMC workstreams around one development strategy
- Practical dos and don’ts for managing risk, maintaining FDA alignment, and keeping accelerated approval programs on track
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