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# ‘Deemed to be a License’ Questions, Answers
- URL: https://www.fdaweb.com/deemed-to-be-a-license-questions-answers/
- Published: 2020-03-04T12:00:00.000Z
- Updated: 2026-09-14T16:05:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146237

FDA has published a guidance to provide answers to common questions about the agency implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009\. Under that act, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deemed-be-license-provision-bpci-act-questions-and-answers?ref=fdaweb.com) says, an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act as of 3/23 will be deemed to be a license for a biological product under section 351 of the Public Health Service Act on 3/23.

The guidance also describes the agency’s compliance policy for the labeling of biological products that are the subject of deemed license applications (BLAs). It is intended to facilitate planning for the transition date and provide further clarity about the agency’s implementation of the statutory provision, FDA says.