Are You Ready for the Future of Real-Time Regulatory Review?

In an era where patient access is paramount, the FDA is moving away from traditional, linear review cycles. The Split Real-Time Application Review (STAR) program represents a massive shift toward agility, allowing sponsors to submit clinical data in “parts” so the FDA can begin its review earlier.

For sponsors of NDAs and BLAs, the STAR program isn’t just a pilot—it’s a competitive advantage. However, the bar for entry is high, and the operational demands are intense. This webinar provides a technical roadmap to navigating the STAR framework, ensuring your team is prepared for the “Real-Time” interaction required to hit the “Minus 1 month” goal.

What We will Cover

This technical webinar breaks down the FDA’s STAR Framework into actionable steps for regulatory, clinical, and data management teams:

• Eligibility Decoded: Which efficacy supplements qualify under the “substantial improvement” and “unmet medical need” criteria?
• The Two-Part Submission Strategy: How to structure “Part 1” (topline results and clinical protocols) and “Part 2” (final CSRs and datasets) within the mandatory 2-month window.
• Operational Velocity: Preparing your team for “Real-Time” interaction—handling FDA queries while the submission is still in progress.
• Timeline Optimization: Tactics to ensure your action date is at least one month faster than the standard 6-month priority review.
• The Pitfalls of STAR: Understanding why foreign site inspections and CMC complexities could disqualify your application.

Why You Should Attend

The STAR Program is a high-stakes, “opt-in” pathway where the margin for error is razor-thin. Unlike standard submissions, STAR requires your clinical and regulatory teams to operate in perfect synchrony with the FDA under a compressed timeline. Attending this webinar is essential because simply having a “breakthrough” drug isn’t enough to qualify—you must demonstrate data maturity and submission readiness that meets the FDA’s specific “real-time” standards. We will move beyond the public guidance to discuss the internal infrastructure needed to handle rapid-fire Information Requests (IRs) and how to decide if the 1-month time savings is worth the intensified operational pressure 

Who Should Attend?

• Regulatory Affairs Professionals aiming for expedited approval paths.
• Clinical Operations Leads managing data locks and topline reporting.
• Project Managers in Drug Development
• Data Managers and Biostatisticians preparing datasets for real-time FDA scrutiny.
• Quality Assurance Professionals in Pharma and Biotech Industries
• Executive Leadership at Biotech and Pharma firms seeking to optimize market entry.