The “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act: Questions and Answers; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "The `Deemed To Be a License' Provision of the BPCI Act: Questions and Answers." This guidance is intended to provide answers to common questions about FDA's implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's implementation of this statutory provision. This guidance finalizes the draft guidance of the same title issued on December 12, 2018.