FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications.

DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.”  Under the final rule, approved BLAs can continue to incorporate by reference information on drug substances, drug substance intermediates, and drug products (“DS/DSI/DP”) contained in DMFs, if the data were referenced at the time of the initial application’s approval.

Notably, Investigational New Drug Applications for biologics can incorporate by reference any information, including DS/DSI/DP information, contained in DMFs.  However, the rule stipulates that BLAs for combination products may only incorporate DS/DSI/DP information by reference for the non-biological constituent of the product, not the biological constituent.

According to the FDA, the final rule codifies longstanding FDA practice and will “avoid unnecessary disruptions and potential drug shortages for these products.”  Ultimately, the FDA predicts that the rule will provide advantages in administrative efficiency and predictability.

The final rule goes into effect on March 13, 2024.