From the polio vaccine to cellular therapies for cancer treatment, biologics help people live longer, healthier lives. To help ensure good manufacturing practices by the industry and to benefit patient safety, the FDA requires the submission of Lot Distribution Reports (LDR) for all products marketed in the U.S. under a Biologics License Application (BLA). Through the LDR program, the FDA is working to make the data submitted regarding these essential products more useful.

This kit provides you with helpful insights and five steps to prepare you for compliance with the FDA"s mandate for electronic LDR submission.