# Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/reference-product-exclusivity-for-biological-products-filed-under-section-351a-of-the-phs-act/7021cd9e-7798-464d-9e2b-7182acf180d8

> FDA guidance document: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act. Issue date: August 04, 2014. Get complete insights and analysis.

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## Details

- Title: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act
- 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: 2014-08-04
- Last Changed: 2020-04-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1165">FDA-2013-D-1165</a>

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