The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). The final rule codifies FDA’s existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.

This Final Regulatory Impact Analysis discusses the economic impacts of the final rule, including costs, cost savings, and benefits. The final rule will generate net cost-saving benefits for the private and government sectors. Furthermore, the final rule will promote continuity and help avoid potential disruptions in the supply of certain biological products.

Biologics License Applications and Master Files (Final Rule) PDF 359 KB

Federal Register: 89 FR 9743
Publication Date: 2/12/2024
Docket: FDA-2019-N-1363