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# Draft Guide on ‘Deemed to be a License’ BLAs
- URL: https://www.fdaweb.com/draft-guide-on-deemed-to-be-a-license-blas/
- Published: 2018-12-12T12:00:00.000Z
- Updated: 2026-09-15T00:50:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143019

*Federal Register* notice: FDA has announced the availability of a draft guidance entitled “The ‘Deemed to be a License’ Provision of the BPCI Act: Questions and Answers.” The document 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 will be deemed to be a license for the biological product under the Public Health Service Act effective 3/23/2020\. It also describes FDA’s compliance policy for labeling biological products that will be the subject of deemed BLAs. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-12/pdf/2018-26855.pdf?ref=fdaweb.com).