Case Study
Label Expansion Supported by a Real-World Evidence (RWE) Study
Apr 15, 2025
In a recent project, a pharmaceutical customer aimed to expand the label of its product to include a new patient population. This expansion required robust regulatory engagement and clear communication with the FDA to ensure the evidence met regulatory requirements. The customer faced the challenge of navigating the complex regulatory landscape to gain approval for the label expansion without relying on traditional Randomized Clinical Trials (RCTs).
Learn how IQVIA collaborated with the sponsor to provide and position the highest quality regulatory-grade data to support the product's path to regulatory approval.