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# Guidance on Biologics License Provisions
- URL: https://www.fdaweb.com/guidance-on-biologics-license-provisions/
- Published: 2016-03-14T12:00:00.000Z
- Updated: 2026-09-15T02:43:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135069

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Implementation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009.* It describes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 The draft guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the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](http:// http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-03-14/pdf/2016-05626.pdf?ref=fdaweb.com).