Data Firms Form Real-World Evidence Alliance, Giving Them A Voice With US FDA, Congress
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.
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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new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.
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.
Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.