This is your year: a summary of real-world evidence in 2021

In 2021, the aim for clear standards on real-world evidence (RWE) from the FDA was put into the limelight. Following the inaugural 21st Century Cures Act, many wondered how the boundaries of clinical trials would be pushed by RWE. At the turn of the year, the FDA had already been focusing on the end of 2021, with draft guidance intended to be published around this time. Specifically, this guidance would summarize the lessons from the past year, utilizing applications involving RWE submitted to the FDA, or demonstration products around RWE conducted by the FDA itself. By the end of the year, the FDA made it clear that RWE had multiple facets...