US FDA’s Current Technical Standards Not A Good Fit For Real-World Data, Stakeholders Say
The agency’s existing technical standards are better-suited to clinical trial data, and mapping RWD to these formats will result in the loss of granularity and introduce new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.
You may also be interested in...
In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do more to publicize the experience to date with RWE in regulatory submissions.
New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.
Established by five real-world data and analytics companies, the new group provides a collective seat at the table for legislative and policy development conversations about real-world evidence and an organized channel of communications with the US FDA.