When you submit new drug applications (NDAs), the U.S. Food and Drug Administration (FDA) requires you to verify the validity of your data and analyses.
According to this document, to demonstrate the validity of the software used for an NDA, you must have
Stata provides all three:
The FDA guidance document further discusses change/version control and documentation of revalidation. All updates to Stata can be obtained by users over the Internet with the simple Stata command update. All changes are documented in Stata’s help system. Users can type help whatsnew or select Help > What's New? from the menu to see, listed by date, all changes that have been made to Stata and included in the currently installed update (as well as previous updates).
Stata has an excellent worldwide reputation for accuracy and quick resolution of all questions. Should any questions arise about using Stata when submitting to any government agency (including the FDA), StataCorp will assist you in resolving the issues by working directly with the government agency, if needed.
Learn
Free webinars
NetCourses
Classroom and web training
Organizational training
Video tutorials
Third-party courses
Web resources
Teaching with Stata
© Copyright 1996–2024 StataCorp LLC. All rights reserved.
×
We use cookies to ensure that we give you the best experience on our website—to enhance site navigation, to analyze usage, and to assist in our marketing efforts. By continuing to use our site, you consent to the storing of cookies on your device and agree to delivery of content, including web fonts and JavaScript, from third party web services.
Cookie Settings
Last updated: 16 November 2022
StataCorp LLC (StataCorp) strives to provide our users with exceptional products and services. To do so, we must collect personal information from you. This information is necessary to conduct business with our existing and potential customers. We collect and use this information only where we may legally do so. This policy explains what personal information we collect, how we use it, and what rights you have to that information.
These cookies are essential for our website to function and do not store any personally identifiable information. These cookies cannot be disabled.
This website uses cookies to provide you with a better user experience. A cookie is a small piece of data our website stores on a site visitor's hard drive and accesses each time you visit so we can improve your access to our site, better understand how you use our site, and serve you content that may be of interest to you. For instance, we store a cookie when you log in to our shopping cart so that we can maintain your shopping cart should you not complete checkout. These cookies do not directly store your personal information, but they do support the ability to uniquely identify your internet browser and device.
Please note: Clearing your browser cookies at any time will undo preferences saved here. The option selected here will apply only to the device you are currently using.