Aetion eBook Notes Half of 2019 Submissions to FDA Included RWE

Aetion has released an eBook detailing trends in regulatory submissions that include real world evidence (RWE). Aetion notes that approximately 50% of 2019 submissions to the Food and Drug Administration (FDA) used RWE. The eBook details RWE in several areas of research, including oncology and infectious disease.

“As industry prepares for the FDA’s draft RWE guidance in 2021, Aetion conducted a systematic review of FDA approval documents in 2019 to understand what role RWE plays in informing regulatory decisions. This eBook will guide you through when, where, and how RWE studies have supported the approvals of NDAs and BLAs, and how Aetion can serve as a partner on your next regulatory submission.” Download the eBook here.

(Source: Aetion, 2021)