Guidance on Biologics License Provisions

Federal Register Notice: FDA is making available a draft guidance for industry entitled Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009. It describes the agency’s approach to implementing the statutory provision under which an application for a biological product approved under the FD&C Act on or before 3/23/20, will be deemed to be a license for the biological product under the Public Health Service Act on 3/23/20. The draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before 3/23/20, to facilitate alignment of product development plans with the agency’s interpretation of the transition provisions of the BPCI Act. To download this guidance, click here. To view this notice, click here.