Updates to the Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020

Updates to the Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020 

The Food and Drug Administration (FDA) posted an updated Preliminary List of Approved New Drug Applications (NDAs) for Biological Products That Will Be Deemed to be Biologics License Applications (BLAs) on March 23, 2020. To enhance transparency and facilitate planning for the March 23, 2020, transition date, FDA posted a preliminary list of approved applications for biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and that will be affected by this statutory transition provision. FDA invited public comment on the preliminary list and explained that the agency intended to periodically update this preliminary list before the March 23, 2020, transition date. The updated preliminary list is current through August 31, 2019.

FDA is working to ensure that there is a seamless transition between regulatory pathways and that there are minimal impacts on manufacturers and patients. More information on the transition can be found on FDA’s webpage for the “Deemed to be a License” Provision of the BPCI Act.