What specific regulatory application involves supporting new indications for an already approved medical product using RWE?
Answer
Label Expansion
Label Expansion is a recognized regulatory application where Real-World Evidence (RWE) provides supportive data for health authorities, like the FDA, to approve new indications or uses for a medical product that has already undergone initial review and approval. This application demonstrates the evolving acceptance of RWE, showing it can be used not just for post-market monitoring but also to actively support expanding a product's approved scope based on data gathered during routine patient use. This process requires high transparency regarding data provenance and analytical methods to meet the necessary rigor expected for regulatory support.
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