NWBO has the potential to collect Real-World Data (RWD) through a compassionate use or expanded access program, assuming patient outcomes are tracked in a consistent and structured way.
According to the FDA’s finalized guidance from August 2023, real-world data includes information about patient health and healthcare delivery that is routinely gathered from various sources.
Expanded access is mentioned among those sources. When this type of data is used to evaluate treatment effects or outcomes, it qualifies as Real-World Evidence (RWE), which the FDA has been giving more weight to in recent years, especially following the passage of the 21st Century Cures Act.
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