It is not new that the FDA requires the submission of Lot Distribution Reports (LDRs) for all products marketed in the U.S. under a Biologics License Application (BLA). However, it is important for BLA holders to know that a new FDA LDR submission format will soon be required to help make the data contained in biologic LDRs more useful.
LDRs are currently accepted in PDF format. However, a final rule issued last year changes the LDR format requirements. The rule goes into effect one year after publication, on June 10, 2015. After June 10, all biologic LDR submissions must be made in Structured Product Labeling (SPL) format and submitted to the FDA through the Electronic Submissions Gateway (ESG).
SPL is a versatile, useful document authoring standard that already is widely used for other electronic submissions to FDA, including NDC Labeler Code Requests, Drug Establishment Registration and Electronic Drug Listing. However, while SPL format does make data more useful, preparing LDR data in the SPL format that will pass validation at the FDA can be challenging. In addition, the FDA Guidance has added some LDR data values not previously reported.
To meet the FDA’s LDR submission mandate on time, BLA holders should begin working now to choose an SPL preparation method. There are three main approaches to creating SPL submissions:
1. SPL XForms Tool: The FDA provides a no-cost software tool for creating various SPL documents. However, the XForms tool can be difficult to use and the files produced may require manual editing prior to submission.
2. Buy or Build Software: Some companies rely on internally installed software (and users) to prepare their data in SPL. This method may be achievable for companies with large regulatory departments. It can be expensive and the responsibilities of installation, validation, maintenance, and upgrades will need to be assumed by the company.
3. Third-Party Service Provider: Many manufacturers prefer to engage a third party to assist in the preparation of SPL documents. Reed Tech is a specialized provider with extensive experience in SPL preparation. We can accept your data, create the SPL, validate it against FDA requirements and return a file that is ready to be included in your BLA supplement submission.