Posted by Michael Wonder on 28 Oct 2021
FDA acknowledges hurdles in utilising real world data
28 October 2021 - FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into submissions to the agency, while addressing concerns about its relevance and reliability.
Despite broad enthusiasm for wider use of real world data and real world evidence in developing and assessing the efficacy and safety of new drugs and medical products, this approach presents significant challenges in assuring that the information is valid and germane to the research involved.
