Registered drug establishments should submit a “Blanket No Change Notification” for all products that have not been updated during the current year to certify there were no changes to the data or labeling as part of their annual registration renewal. The notification must be submitted in structured product labeling (SPL) format. Structuring data in SPL format requires SPL authoring software. The SPL files can be submitted to FDA via the Agency’s Electronic Submission Gateway (ESG). Users may also use CDER Direct to submit for human drug listings. According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.
