FDA Announces Public Meeting on Use of Real-World Evidence

The FDA will hold a public workshop on regulatory use of real-world evidence September 13.

The agency will hold the meeting in the District of Columbia to discuss numerous subtopics including its activities on use of RWE in regulatory decisions, developing guidance for acceptability challenges and discussions of how to improve data collection and analytics to develop the most reliable evidence.

The agency is seeking information on challenges presented by the use of RWE to inform its analysis. Real-world evidence has so far been used in limited contexts such as historical controls for rare disease treatments and postmarket safety surveillance.