Janet Woodcock, MD—Director—Center for Drug Evaluation and Research (CDER)
Thank you for your interest in CDER’s data standards. We recognize that using data standards is a big shift for industry, but we think it’ll be really helpful for developers as well as the FDA staffers. Data standards help our reviewers organize the data and also help them access the data much more efficiently, saving time.
To help you use our data standards, we’ve created guidance and data validation rules that you can apply. In fact, we even have acceptance of sample data submissions that you can use to see if your data will be acceptable. We really encourage you to use our standards, and we are available to answer any questions you might have.
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