On-Demand Webinar
US Regulatory Approval & Successful Payor Negotiations
The US FDA and payers are increasingly using real-world evidence (RWE) to support regulatory approvals, formulary positioning, and label expansions. This webinar explores how sponsors can efficiently apply RWE across the product lifecycle, align with FDA guidance, integrate it into clinical trials, and navigate payer and regulatory expectations—plus insights on the Inflation Reduction Act.
Topics covered in this webinar include:
What recent activities has the FDA conducted around RWE?
What aspects of the FDA’s RWE guidance are most relevant for study sponsors?
How can RWE be used during the pre-, peri-, and post-approval phases of product development?
Do RWE use cases differ for regulatory and payer submissions?
How can RWE be integrated into my clinical trial program?
What common pitfalls should be avoided when using RWE for these activities?
What is the current status of the Inflation Reduction Act in the US?
