The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.

ABSTRACT: The US Food and Drug Administration (FDA) is open to accepting real-world evidence (RWE) to support its assessment of medical products. However, RWE stakeholders lack a shared understanding of FDA's evidentiary expectations for the use of RWE in applications for new drugs and biologics. We conducted a systematic review of publicly available FDA approval documents from January 2019 to June 2021. We sought to quantify, by year, how many approvals incorporated RWE in any form, and the intended use of RWE in those applications. Among approvals with RWE intended to support safety and/or effectiveness, we classified whether and how those studies impacted FDA's benefit-risk considerations, whether those studies were incorporated into the product label, and the therapeutic area of the medical prod

SUBMITTER: Purpura CA 

PROVIDER: S-EPMC9299054 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature