At Last! FDA Issues Final Guidance on Use of Real-World Evidence for Regulatory Decision-Making for Drug and Biological Products

Please join our panel for an analysis of key takeaways from FDA’s final guidance issued in August 2023 regarding the use of real-world data (RWD) to develop real-world evidence (RWE) to support regulatory decision-making for drugs and biological products. We will focus on how FDA clarifies and imposes new and more rigorous expectations for sponsors regarding collection and analysis of RWD to develop RWE to ensure that “particular data sources or databases were not selected, or that specific analyses were not conducted, to favor a certain conclusion.” Learn about the issues that may trigger major changes in the policies and practices that your company is currently using to identify and collect RWD developed during routine medical practice to develop RWE, as well as new implications for public disclosures, including:  

•  FDA emphasis on observational cohort studies and case-control studies
•  Data privacy and security issues that are implicated when accessing health care data
•  FDA review of draft protocols and statistical analysis plans (SAPs) prior to collection and analysis of data
•  Voluntary disclosure of study protocols on ClinicalTrials.gov
•  Enabling and maintaining audit trails
•  Ensuring FDA access to patient-level data