# Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 :  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/interpretation-of-the-deemed-to-be-a-license-provision-of-the-biologics-price-competition-and-innovation-act-of-2009-guidance-for-industry/154bca51-03bf-47a8-8b5d-81c56ff9454a

> FDA guidance document: Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 :  Guidance for Industry. Issue date: December 12, 2018. Get complete insights and analysis.

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## Details

- Title: Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 :  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2018-12-12
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-4750">FDA-2015-D-4750</a>

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