FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this transition into your regulatory strategy. Holders of NDAs for biological products and those developing NDAs or ANDAs for biological products should carefully consider the potential impacts on their pre- and post-approval requirements in order to be prepared for the change and minimize any delay of approval of their application.