Expired FDA Forms

The Agency has been receiving many inquiries from the pharmaceutical industry asking about the validity of expired FDA forms and when new versions will be available. FDA staff work with the Office of Management and Budget (OMB) to update and renew the expired form(s) for posting on the FDA Forms webpage. The forms posted on this webpage may be used even if they appear to have an expiration date that has passed. 

Unfortunately, we do not have a specific date that you will see a new form, as it depends on OMB’s workload. Every 3 years these forms should be renewed with a new expiration date regardless of any changes to the actual forms. 

If you haven’t yet signed up to follow SBIA on LinkedIn, we encourage you to do so as we often announce webinars related to significant changes in forms and other items of interest to the pharmaceutical industry.

Please continue to use the forms on the FDA Forms webpage until new forms are posted.