Real-world evidence (RWE) is increasingly important in clinical trial design and drug approval. RWE is clinical evidence related to patient health status and treatment safety and efficacy that are generated in clinical practice. The FDA developed a framework to use RWE, which may combine with orphan, fast track, breakthrough therapy designation, and accelerated approval to […]
Tagged: Accelerated Drug Approval
BBCR’s team of experts is highly experienced in the areas of Real World Evidence (RWE) for Control Arm, Post-approval Requirements and Disease Natural History. Reach out today to learn more.
September 8th, 2022 | Accelerated Drug ApprovalCategories
- Biomarkers & Surrogate Endpoints
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