US FDA’s Current Technical Standards Not A Good Fit For Real-World Data, Stakeholders Say

10 May 2022

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new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.

The US Food and Drug Administration is trying to shoehorn real-world data into existing technical standards that are better-suited to clinical trial data, pharmaceutical industry stakeholders and data companies say.

In comments on the FDA’s draft guidance on data standards for drug submissions containing real-world data, stakeholders raise concerns about...