FDA’s drug development tool-focused ISTAND pilot accepts its first submission

Nearly two years after the creation of a pilot program intended to assist with the development of novel drug development tools, the FDA has announced that the first-ever submission has been accepted to the program, known as ISTAND. But even as the tool is the first through the gates, it’s likely to be years before the tool is ready for full qualification.

Regulatory Background

Drug Development Tools (DDTs) are generally used to evaluate or create clinical endpoints and can include things like clinical outcome assessments, biomarkers and animal models. In short, they demonstrate that a method, material or measure is meaningful and can be relied upon during the drug development process.

Fill out the form to read the full article.