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The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers Guidance for Industry December 2018

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
Issued by:
Guidance Issuing Office
Office of Regulatory Policy
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.” This draft guidance is intended to provide answers to common questions about FDA's interpretation of the statutory provision under which an application for a biological product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 interpretation of this statutory provision. FDA also invites comment on the preliminary list of approved new drug applications (NDAs) for biological products under the FD&C Act that will be deemed to be BLAs on the transition date.

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Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2018-26855.