# The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers :  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/the-deemed-to-be-a-license-provision-of-the-bpci-act-questions-and-answers-guidance-for-industry/fdd76b2b-bf3b-4f6d-9988-59d75e496a17

> FDA guidance document: The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers :  Guidance for Industry. Issue date: March 04, 2020. Get complete insights and analysis.

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## Details

- Title: The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers :  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2020-03-04
- Last Changed: 2020-03-04
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-4750. ">FDA-2015-D-4750. </a>

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