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GUIDANCE DOCUMENT

The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers Guidance for Industry March 2020

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2015-D-4750.
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy
Center for Biologics Evaluation and Research

This guidance is intended to provide answers to common questions about FDA’s implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) on March 23, 2020 (the transition date). This guidance also describes FDA’s compliance policy for the labeling of biological products that are the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the transition date and provide further clarity regarding the Agency’s implementation of this statutory provision.

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All written comments should be identified with this document's docket number: FDA-2015-D-4750. .

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