Post by IQVIA

Name: FDA’s Rare Disease Evidence Principles (RDEP) build on existing guidance to provide greater clarity
Uploaded: 2026-06-17T11:00:14.924Z
Channel: IQVIA
Description: FDA’s Rare Disease Evidence Principles (RDEP) build on existing guidance to provide greater clarity for ultra-rare drug development. For sponsors working in small populations where randomized trials a

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FDA’s Rare Disease Evidence Principles (RDEP) build on existing guidance to provide greater clarity for ultra-rare drug development. For sponsors working in small populations where randomized trials are often not feasible, RDEP outlines clearer evidentiary expectations, reinforcing the role of innovative study designs and high-quality real-world evidence (RWE) in regulatory decision-making. Learn more: https://bit.ly/4fGwJbh

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