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Regulatory & Access Resources

Browse our regulatory & access resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

Over the past decade, there has been a proliferation of real-world data (RWD) sources that sponsors can use to generate real-world evidence (RWE) for a wide range of purposes across the product development lifecycle. In addition to traditional claims and administrative data, they now have access to even higher-quality patient-level and regulatory-grade data generated by healthcare systems.